Helistat ® ABSORBABLE COLLAGEN HEMOSTATIC SPONGE 3410-ZX

GUDID 10381780000204

Collagen haemostatic agent

Primary Device ID	10381780000204
NIH Device Record Key	5bdb799d-5d44-46d7-8378-a1d5ad5cdd69
Commercial Distribution Status	In Commercial Distribution
Brand Name	Helistat ® ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
Version Model Number	3410-ZX
Catalog Number	3410-ZX
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

Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity

Device Issuing Agency	Device ID
GS1	00381780000207 [Primary]
GS1	10381780000204 [Package] Contains: 00381780000207 Package: Box [10 Units] In Commercial Distribution
HIBCC	M2693410ZX0 [Secondary]

LMF	Agent, Absorbable Hemostatic, Collagen Based

Steralize Prior To Use	false
Device Is Sterile	true

10381780268536 - Omni-Tract®	2024-07-18 Omni-Tract® Arm, Fixed Angle, 8in x 12in (20.3cm x 30.5cm) x 75°
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)

Mark Image Registration \| Serial	Company Trademark Application Date
HELISTAT 78222444 3351918 Dead/Cancelled	AlgoPlus Consulting Limited 2003-03-06
HELISTAT 73528301 1361378 Live/Registered	HELITREX, INC. 1985-03-22