AccessGUDID - DEVICE: LimiTorr™ (10381780112228)

GUDID

Device Identifier (DI) Information

Brand Name: LimiTorr™
Version or Model: INS400L
Commercial Distribution Status: In Commercial Distribution
Catalog Number: INS400L
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780112228
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: The Pole Mount Laser Level device is provided with mounting bracket for use with Integra Pole Mount Assemblies. The Pole Mount Laser provides alignment for the External CSF Drainage and Monitoring Systems. These systems are used for draining CSF from an intraventricular catheter or lumbar catheter to an external ventricular drainage system.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
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?
61798	Ventricular cerebrospinal fluid drainage catheterization kit	A collection of sterile devices intended for short-term access to the brain ventricles to drain cerebrospinal fluid (CSF) as a means of reducing CSF volume and intracranial pressure (ICP). It includes an intracerebral infusion/drainage catheter and devices intended for catheter insertion (e.g. stylet) and CSF collection (e.g., drip chamber, drainage bag, tubing set). 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 [?]
K062599	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bb15d656-6374-4047-b9c8-04a24db7ae99
Public Version Date: December 23, 2024
Public Version Number: 6
DI Record Publish Date: September 22, 2015