Suturable Tubing Clamp

Basic Information

• Brand Name: Suturable Tubing Clamp
• Primary DI: 10381780034445
• Version / Model: 999004
• Catalog Number: 999004
• Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
• Labeler DUNS: 531408342
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-01
• Public Version: 4
• Public Version Date: 2023-02-17
• Public Version Status: Update
• Public Device Record Key: 5f916661-2c09-4eb2-ad25-48cc403ac64d
• Distribution End Date: 2021-06-30

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

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JXG	Shunt, central nervous system and components	Neurology	882.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780034445	GS1
Secondary	M2729990041	HIBCC
Package	30381780034449	GS1	BOX	5	Not in Commercial Distribution	2021-06-30

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K101381	000
K944595	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			2.25mm O.D. (F7)

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Room temperature