AccessGUDID - DEVICE: Gomco Type Circumcision Clamp (00869401000268)

GUDID

Device Identifier (DI) Information

Brand Name: Gomco Type Circumcision Clamp
Version or Model: 903-018
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 903-018
Company Name: FINE SURGICAL INSTRUMENTS INC.

Primary DI Number: 00869401000268
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 103669727 *Terms of Use

Device Description: Gomco Type Circumcision Clamp Stainless Steel (German) Infant 1.45cm

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	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?
10869	Circumcision clamp, reusable	A hand-held manual surgical instrument designed for the controlled removal of the foreskin of the penis during circumcision. It is typically made of high-grade stainless steel and can have various designs, e.g., the Bell clamp. The foreskin is pushed over the bell-shaped protection rod and the glans placed into it. A screw mechanism is tightened so that the foreskin is annular compressed and is cut-off using, e.g., a scalpel, following the compression ring. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HXD	CLAMP

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Gomco Type CC S/less (German) Infant 1.45cm

Device Record Status

Public Device Record Key: 7d9c0a7c-a26b-4572-ba9a-4e7a4d84827e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 10, 2016