AccessGUDID - DEVICE: CODMAN® (10381780511588)

GUDID

Device Identifier (DI) Information

Brand Name: CODMAN®
Version or Model: 201025
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20-1025
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780511588
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: CODMAN® RANEY Scalp 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:	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?
34959	Scalp haemostasis clip, reusable	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 or is made of a single alpha-shaped part. It is typically made of high-grade stainless steel. This is a reusable 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: 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
No Device Sizes

Device Record Status

Public Device Record Key: dd9a930a-65c0-4102-bc4c-c3dd92f7570d
Public Version Date: April 14, 2023
Public Version Number: 5
DI Record Publish Date: February 28, 2020