AccessGUDID - DEVICE: Suturable Tubing Clamp (10381780034452)

GUDID

Device Identifier (DI) Information

Brand Name: Suturable Tubing Clamp
Version or Model: 999005
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 999005
Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Primary DI Number: 10381780034452
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 531408342 *Terms of Use

Device Description: The Integra Suturable Tubing Clamps are sterile single use devices designed to secure a ventricular or a lumbar catheter to the surrounding tissues by means of non-absorbable suture. They consist of a butterfly shaped radiopaque silicone tubing with two suture holes. They feature a slit for introduction of the catheter. They are available in three inner diameters to anchor Integra NeuroSciences catheters presenting a F5 (OD=1.65mm), F7 (OD=2.25mm), or F8 (OD=2.65mm) outer diameter (OD).

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	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?
61111	Intracranial catheter holder	A small, sterile device designed to secure an intracranial catheter (e.g., intracerebral sensor catheter, intracerebral infusion/drainage catheter, epidural sensor catheter) to the skin; it may also be used as a marker for the planned depth of the catheter insertion. It typically has a gripping mechanism which creates a right angle bend in the tube, and is intended to be held in place with sutures. 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 [?]
K101381	000
K944595	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
Special Storage Condition, Specify: Room temperature

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1.65mm O.D. (F5)

Device Record Status

Public Device Record Key: b61b35ba-0bd8-4baa-883e-bf656f8e3bac
Public Version Date: February 17, 2023
Public Version Number: 4
DI Record Publish Date: October 01, 2015