AccessGUDID - DEVICE: CODMAN® BACTISEAL® (10381780537083)

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: 10381780537083
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: CODMAN® BACTISEAL® 23cm Ventricular Catheter MR Conditional Contents: Ventricular Catheter 23cm (1), Right Angle Adapter (1); Additional Contents: Stylet (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?
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
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 2 and 27 Degrees Celsius
Special Storage Condition, Specify: Do not use if package is damaged, Keep away from sunlight
Handling Environment Temperature: between 2 and 27 Degrees Celsius
Storage Environment Temperature: between 36 and 81 Degrees Fahrenheit
Handling Environment Temperature: between 36 and 81 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Catheter Length: 23 Centimeter

Device Record Status

Public Device Record Key: 93be4a0e-4594-4cc3-b1db-14a8569e22a0
Public Version Date: March 24, 2025
Public Version Number: 2
DI Record Publish Date: November 20, 2024