AccessGUDID - DEVICE: CODMAN® BACTISEAL® (10381780537113)

GUDID

Device Identifier (DI) Information

Brand Name: CODMAN® BACTISEAL®
Version or Model: NS5074
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NS5074
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780537113
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: CODMAN® BACTISEAL® Catheter MR Conditional Contents: Peritoneal Catheter 120cm (1)

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
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?
61159	Peritoneal/atrial cerebrospinal fluid catheter	A flexible tube intended to be implanted as the distal component of a ventriculo-peritoneal/atrial shunt, to channel cerebrospinal fluid (CSF) to either the peritoneal cavity or the right atrium (i.e., dual-capability) where it can be absorbed into the body. It is intended to be part of a therapeutic measure for situations where excess CSF causes elevated intracranial pressure (hydrocephalus). Disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JXG	Shunt, central nervous system and components
HCA	CATHETER, VENTRICULAR

FDA Premarket Submission

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

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
Storage Environment Temperature: between 36 and 81 Degrees Fahrenheit
Handling Environment Temperature: between 2 and 27 Degrees Celsius
Storage Environment Temperature: between 2 and 27 Degrees Celsius
Handling Environment Temperature: between 36 and 81 Degrees Fahrenheit
Special Storage Condition, Specify: Do not use if package is damaged, Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Catheter Length: 120 Centimeter

Device Record Status

Public Device Record Key: 1abb30d8-9d31-4a64-b0e5-6bebcc51dd5a
Public Version Date: March 24, 2025
Public Version Number: 2
DI Record Publish Date: November 20, 2024