Hermetic Plus™ INS8301

GUDID 10381780537434

Ventricular cerebrospinal fluid drainage catheterization kit

Primary Device ID	10381780537434
NIH Device Record Key	f1bdbfb7-fffd-434e-9276-a011fbb52d8e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Hermetic Plus™
Version Model Number	INS8301
Catalog Number	INS8301
Company DUNS	083171244
Company Name	Integra Lifesciences Corporation
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	10381780023869 [Previous]
GS1	10381780537434 [Primary]

JXG	Shunt, central nervous system and components

Steralize Prior To Use	false
Device Is Sterile	true

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10381780269106 - Omni-Tract®	2024-07-18 Omni-Tract® Malleable Swivel Blade with 3/8in (1.0cm) Hole, 1.5in x 3in (3.8cm x 7.6cm)
10381780269113 - Omni-Tract®	2024-07-18 Omni-Tract® Malleable Swivel Blade with 3/8in (1.0cm) Hole, 1.5in x 4in (3.8cm x 10.2cm)
10381780538134 - Omni-Tract®	2024-07-18 Omni-Tract® Malleable Swivel Blade with 3/8in (1.0cm) Hole, 1.5in x 5in (3.8cm x 12.7cm)
10381780538158 - Omni-Tract®	2024-07-18 Omni-Tract® Malleable Swivel Blade with 3/8in (1.0cm) Hole, .75in x 2in (1.9cm x 5.1cm)
10381780538165 - Omni-Tract®	2024-07-18 Omni-Tract® Malleable Swivel Retractor, 1in x 3in (2.5cm x 7.6cm) Mini
10381780538172 - Omni-Tract®	2024-07-18 Omni-Tract® Medial Retractor, 1.5in x 3.5in (3.8cm x 8.9cm)
10381780538189 - Omni-Tract®	2024-07-18 Omni-Tract® Meyerding Retractor, Blunt, 1in x 3in (2.5cm x 7.6cm)