ShangRing

Basic Information

• Brand Name: ShangRing
• Primary DI: 16939550822149
• Version / Model: W
• Company Name: Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd.
• Labeler DUNS: 546495560
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-19
• Public Version: 1
• Public Version Date: 2021-03-29
• Public Version Status: New
• Public Device Record Key: d4b814f1-58a4-40df-acab-bb6c73d6736d

Device Description

ShangRing Male Circumcision Device Self-locking

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HFX	Clamp, Circumcision	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38523	Surgical penis clamp, single-use	A sterile, hand-held manual surgical instrument designed to grasp the penis for manipulation during surgery (e.g., circumcision). It is typically a clip-like device e.g., with self-retaining levers. The penis is placed into this clamp that closes around or on the organ. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	26939550822146	GS1		10	In Commercial Distribution
Primary	16939550822149	GS1
Package	86939550822148	GS1		20	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K121789	000