AccessGUDID - DEVICE: CODMAN® (10381780520368)

GUDID

Device Identifier (DI) Information

Brand Name: CODMAN®
Version or Model: 826612
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 82-6612
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780520368
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: CODMAN® Cranial Access Kit

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?
61401	Intracerebral catheter cranial-fixation kit	A collection of sterile devices intended to be used to affix an intracerebral sensor/infusion/drainage catheter on the skull of a patient. It includes cranial screws and screwing tools; it does not include the intracerebral catheter, and does not include devices intended for long-term implantation (> 30 days). 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 [?]
K914479	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ecefc2ac-2960-4f6c-9ddd-456ab0209bc1
Public Version Date: April 14, 2023
Public Version Number: 5
DI Record Publish Date: February 28, 2020