AccessGUDID - DEVICE: CODMAN (20886704001130)

GUDID

Device Identifier (DI) Information

Brand Name: CODMAN
Version or Model: 20-1034
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 201034
Company Name: Cerenovus, Inc.

Primary DI Number: 20886704001130
Issuing Agency: GS1
Commercial Distribution End Date: September 01, 2022
Device Count: 200
Labeler D-U-N-S® Number*: 607846297 *Terms of Use

Device Description: CODMAN LEROY-RANEY Scalp Clips 20 Units of 10 Clips

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):	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?
37458	Scalp haemostasis clip, single-use	A small, manually-operated and applied surgical device used to stop bleeding from the scalp during surgery on the cranium. It is is usually applied to the scalp using the fingers or a dedicated pair of scalp clip forceps, and consists of two blades that are joined at a midpoint. It is typically made of plastic materials. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HBO	CLIP, SCALP

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 4addd0c7-2422-4059-89a1-05e72aa32ed3
Public Version Date: September 15, 2023
Public Version Number: 5
DI Record Publish Date: June 30, 2016