AccessGUDID - DEVICE: CODMAN® (10381780514879)

GUDID

Device Identifier (DI) Information

Brand Name: CODMAN®
Version or Model: 801197
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 80-1197
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780514879
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use
Previous DI: 10886704036050

Device Description: CODMAN® Disposable ICP Kit, Plastic, Pediatric

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:	Yes
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?
56302	Craniotomy kit	A collection of various sterile basic instruments, dressings and the necessary materials used to perform a craniotomy procedure. It typically includes scalpels, retractors, forceps, sutures, but does not contain pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWM	Device, monitoring, intracranial pressure

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K853770	000

Device Exempt from Premarket Submission: No 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
Handling Environment Temperature: between 68 and 77 Degrees Fahrenheit
Storage Environment Temperature: between 68 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6010546f-e42f-46f6-b8fb-57a47cd74b77
Public Version Date: June 24, 2025
Public Version Number: 5
DI Record Publish Date: April 01, 2020