AccessGUDID - DEVICE: GREUNSION CIRCUMCISION CLAMP (B0995404010)

GUDID

Device Identifier (DI) Information

Brand Name: GREUNSION CIRCUMCISION CLAMP
Version or Model: 540-401
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: B0995404010
Issuing Agency: HIBCC
Commercial Distribution End Date: June 18, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: GREUNSION CIRCUMCISION CLAMP SIZE 1

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:	No
Prescription Use (Rx):	Yes
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?
35803	Surgical penis clamp, reusable	A 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 reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HFX	Clamp, Circumcision

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K040052	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 7.5 Inch

Device Record Status

Public Device Record Key: 3e27c125-c515-4e8f-b93e-d44c86b60f52
Public Version Date: July 06, 2018
Public Version Number: 7
DI Record Publish Date: August 19, 2016