AccessGUDID - DEVICE: CODMAN® BACTISEAL® (10381780524083)

GUDID

Device Identifier (DI) Information

Brand Name: CODMAN® BACTISEAL®
Version or Model: NS0343
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NS0343
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780524083
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: CODMAN® BACTISEAL® Programmable Cylindrical Valve with Rickham Reservoir and Unitized SIPHONGUARD' Device and Distal Catheter Programmable in steps of 10mnm H2O (98 Pa) 30mm H2O to 200mm H2O (294Pa. 1900Pa) Includes 120cm Distal Length including SIPHONGUA

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?
61376	Intracerebral infusion/drainage catheter, long-term	A sterile, flexible tube intended to be surgically inserted through the skull for long-term (> 30 days) subdural access to the brain (e.g., cerebral ventricles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents); it is typically used for measurement of intracranial pressure (ICP) and as part of a shunt system. It may include an attached port/reservoir at its proximal end that is placed subcutaneously to facilitate material infusion/collection, and/or accessory devices intended to facilitate catheter introduction and/or stabilization (e.g., stylet, catheter holder); it does not include a sensor. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JXG	Shunt, central nervous system and components

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
Handling Environment Temperature: between 2 and 27 Degrees Celsius
Storage Environment Temperature: between 36 and 81 Degrees Fahrenheit
Storage Environment Temperature: between 2 and 27 Degrees Celsius
Handling Environment Temperature: between 36 and 81 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 23 Centimeter

Device Record Status

Public Device Record Key: 5b6b9644-b494-42c1-9068-3d9cba084aca
Public Version Date: March 14, 2024
Public Version Number: 5
DI Record Publish Date: April 01, 2020