AccessGUDID - DEVICE: Lumbar Catheter Accessory Kit (10381780034124)

GUDID

Device Identifier (DI) Information

Brand Name: Lumbar Catheter Accessory Kit
Version or Model: 910121
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 910121
Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Primary DI Number: 10381780034124
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 531408342 *Terms of Use

Device Description: The Lumbar Catheter Accessory Kit (LCAK) is designed for cerebrospinal fluid drainage, and consists of: a 80 cm radiopaque lumbar catheter (F5) with graphite based length marks at 2 cm intervals (first mark at 10 cm from the closed tip); a guidewire in dispenser; a Luer-lock connector; a butterfly suture clamp; a 14-ga, thin-wall Tuohy needle with obturator.

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":	Yes
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?
61797	Lumbar cerebrospinal fluid drainage catheterization kit	A collection of sterile devices intended for short-term percutaneous access to the subarachnoid (intrathecal) or epidural space of the lumbar spinal column to drain cerebrospinal fluid (CSF) as a means of reducing CSF volume and intracranial pressure (ICP). It includes a spinal infusion/drainage catheter and devices intended for catheter insertion (e.g. Tuohy needle, suture, guidewire) and CSF collection (e.g., drip chamber, drainage bag, tubing set, filter). This is a single-use device.	Active	false

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Lumbar Cath. 80cm Length x 1.6mm O.D. x 0.8mm I.D. (F5), 14G Tuohy Needle

Device Record Status

Public Device Record Key: 7bc6f183-d341-40f3-bf8b-b4231b11f513
Public Version Date: December 23, 2024
Public Version Number: 5
DI Record Publish Date: October 01, 2015