AccessGUDID - DEVICE: CODMAN® (10381780511625)

GUDID

Device Identifier (DI) Information

Brand Name: CODMAN®
Version or Model: 201037
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20-1037
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780511625
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 081277700 *Terms of Use
Previous DI: 20886704001154

Device Description: CODMAN® 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: 86954019-76fd-4836-9e1f-d7dde35c413e
Public Version Date: June 24, 2025
Public Version Number: 6
DI Record Publish Date: February 28, 2020