Helistat® ABSORBABLE COLLAGEN HEMOSTATIC SPONGE

Basic Information

• Brand Name: Helistat® ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
• Primary DI: 00381780000191
• Version / Model: 1690-ZZ
• Catalog Number: 1690-ZZ
• Company Name: Integra Lifesciences Corporation
• Labeler DUNS: 083171244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-11
• Public Version: 5
• Public Version Date: 2020-09-22
• Public Version Status: Update
• Public Device Record Key: 9bfdffa4-df63-40aa-a375-d234fefa1511

Device Description

ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, 1/2IN X 1IN, 7MM THICK

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
LMF	Agent, Absorbable Hemostatic, Collagen Based	General, Plastic Surgery	878.4490	3

GMDN Terms

Code	Name	Definition	Implantable	Status
47201	Collagen haemostatic agent, non-antimicrobial	A bioabsorbable device derived from animal collagen (e.g., bovine or porcine collagen) designed to produce a rapid haemostasis through platelet activation/aggregation (which initiates the haemostatic cascade leading to a fibrin clot) during a surgical procedure. It is applied directly to the wound where it remains to be absorbed by the body; it is not dedicated to a specific anatomy/application and does not contain an antimicrobial agent. It may be supplied as a fibrillar or soft, pliable pad/sponge or loose fibres; it may be applied in combination with fibrin adhesives. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10381780000198	GS1	Box	18	In Commercial Distribution
Primary	00381780000191	GS1
Secondary	M2691690ZZ0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
P850010	007

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1.27 cm x 2.54 cm x 7.0 mm
Device Size Text, specify			1/2 in x 1in x 7.0 mm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Avoid excessive heat and humidity