AccessGUDID - DEVICE: Gomco Type Circumcision Clamp (00869401000206)

GUDID

Device Identifier (DI) Information

Brand Name: Gomco Type Circumcision Clamp
Version or Model: 28-854
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 28-854
Company Name: FINE SURGICAL INSTRUMENTS INC.

Primary DI Number: 00869401000206
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 Disposable Chrome Plated, XSML 1.1cm

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:	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?
38525	Circumcision clamp, single-use	A sterile, hand-held manual surgical instrument designed for the controlled removal of the foreskin of the penis during circumcision. It is typically made of metal and/or plastic materials 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 single-use device.	Obsolete	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

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Gomco Type CC Disposable Chrome Plated XSML 1.1cm

Device Record Status

Public Device Record Key: 6d9f3ca3-0184-490b-954c-b05f92224ee7
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 10, 2016