AccessGUDID - DEVICE: Hermetic™ External Drainage Lumbar Catheter (10381780072553)

GUDID

Device Identifier (DI) Information

Brand Name: Hermetic™ External Drainage Lumbar Catheter
Version or Model: SP0224
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SP0224
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780072553
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: LUMBAR CATHETER CLOSED TIP The 80cm barium impregnated silicone lumbar catheter has a closed radiopaque tip and is supplied with a Teflon coated stainless steel guide wire and end stop for assisting catheter placement. Approximately 18mm of the tip is multi-perforated to help improve flow and decrease the possibility of obstruction. Designed for diverting fluid from the lumbar subarachnoid space, the catheter can be inserted with a Tuohy needle using percutaneous techniques. The external portion of the catheter is secured to the subcutaneous tissue in the lumbar area by the suture collar. A 14-guage thin wall Tuohy needle with obturator, guide wire, and 22-gauge blunt needle are included. A female luer adapter and train relief tubing is also included. Two suture collars may be wrapped around the catheter and may be anchored in place with a suture.

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:	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 [?]
K970658	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
Device Size Text, specify: 80cm Hermetic Lumbar Catheter Closed Tip (0.7mm I.D. x 1.5mm O.D.)

Device Record Status

Public Device Record Key: 3bed075f-6137-425c-9ff2-09939071d398
Public Version Date: December 23, 2024
Public Version Number: 6
DI Record Publish Date: September 22, 2015