AccessGUDID - DEVICE: ShangRing (16939550822248)

GUDID

Device Identifier (DI) Information

Brand Name: ShangRing
Version or Model: M
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd.

Primary DI Number: 16939550822248
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 546495560 *Terms of Use

Device Description: ShangRing Male Circumcision Device Self-locking

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HFX	Clamp, Circumcision

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121789	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 159504a0-0e2a-45d5-bfe8-bf54a4a9bc05
Public Version Date: March 29, 2021
Public Version Number: 1
DI Record Publish Date: March 19, 2021