A minimally invasive disposable male circumcision device
Instructions for Use of ShangRing™ Model: Generation II, Self-locking Version 1.1 (Outside the U.S.A.) Release Date: June 2, 2015
Regulatory Statement CAUTION: For professional use only.
Indications for Use The ShangRing™ device is indicated for male circumcision, defined as circumferential excision of the foreskin or prepuce at or near the level of coronal sulcus. The ShangRing is indicated for use in adolescent and adult males ages 13 years and above. Intended Users Health care providers are medical professionals and can include medical doctors, nurses and clinical officers.
Device Description The ShangRing, manufactured by Wuhu Snnda Medical Treatment Appliance Technology Co., LTD., Wuhu City, China, is a sterile, single use, disposable male circumcision device that consists of two concentric plastic rings, the inner of which is lined by a silicone pad. The ShangRing is available in 18 sizes (A4 to S), with inside diameters of 40mm to 18mm. Hemostasis is realized by the pressure applied by the interlocking rings which minimizes bleeding and eliminates the need for sutures.
The photographs below show the ShangRing in the open position, Figure 1, and in the closed/locked position, Figure 2.
Company profiles:
China Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd, a science and technology innovation-oriented enterprise with strong R&D, manufacturing and sales capabilities. Founded in June 2005 by Mr Jiang-zhong Shang, the company is headquartered at the Service Center for Science & Technology Innovation at Wuhu Economic & Technological Development Zone(state level). As one of the global partners of Bill & Melinda Gates Foundation, Wuhu Snnda has been a leader in the field of HIV/AIDS prevention using male circumcision devices.Our leading product, ShangRing Disposable Micro-injury Peritomy Anastomosis Device, has been the first product in the world to standardized procedure for male circumcision through its innovative design. Currently, the company is qualified for GMP and ISO 13485:2003, and honored as a state-level high-tech enterprise.
Product Description
What is ShangRing?
ShangRing Disposable Micro-injury Peritomy Anastomosis Device can solve the problem of redundant prepuce and phimosis within 3 to 5 minutes. It is used by surgeon in hospitals or clinics.
Structure:
The ShangRing is comprised of two concentric plastic rings: an inner ring and outer ring. The inner ring lined with a soft silicone pad, leaving a smooth surface against the surgical wound. The outer ring consists of two halves that are hinged together at one end and contain a locking clasp on the other.
Safety, minimal invasion, easy to perform and cosmetic results
Intra-operation
Frequent intraoperative bleeding and hard to stop it by conventional approaches;
Circumcision by laser leading to the damage to the vessels and tissues and requiring suture
Free of surgical knife and sutures
Severe pain
Less pain
Time consumption>30 min
Time consumption<3~5 min
Post-operation
Requirement of antibiotics against infection
Exceptional oral use of antibiotics when necessary
Contradiction to bath and confinement of bed rest
Bath at patients' option and permission of regulaer work and activities
Visual scars due to irregular sutures, poor cosmetic results
No scars; excellent cosmetic results
Frequent delayed postoperative bleeding
Rare postoperative bleeding
Results
No standardized operating procedure;
Higher postoperative risk factors
Standardized surgical performance;
No risk factors
Description of Phomosis and Redundant Prepure?
In accordance with medical term, phimosis is defines as an abnormal constriction of the foreskin that prevents it from being drawn back to uncover the glans penis. Whereas, redundant prepuce is described as that the foreskin covers the glans penis excessively in flaccidness but is capable of being retracted to uncover it.
Certificate:
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Packaging & Shipping
Package:
FAQ:
1) When?
Usually on the first and second day after birth, although in Judaic practice it’s performed on the eighth day. The procedure is more complicated and riskier for old babies, children and adult males. It may be used as a treatment for phimosis, penile infection or related conditions in older boys and adult males.
2) How?
The excess foreskin is clamped and then clipped off. If done in the immediate post-birth period, the procedure takes five to 10 minutes. Adult circumcision can take as long as 60 minutes. The wound usually heals in five to seven days!
3) Is it necessary?
In December, the US Center for Disease Control and Prevention decide that the benefits of circumcision outweigh and risks, such as bleeding and infection. Although the American Academy of Pediatrics believes that to be true for newborns, it said the benefits are not great enough to recommend universal newborn circumcision.
4) What about older patients?
In China, doctors recommend 8 to 13 as the best age bracket for the surgery, because the body heals more quickly in pre-adolescents, and prepubescent children are unlikely to have reactions that could complicate the postoperative period, such as involuntary erections.
5) What should parents do!
Parent should talk with their doctors about the benefits and risks before making a decision regarding their child.
