Helitene®

Basic Information

• Brand Name: Helitene®
• Primary DI: 00381780000221
• Version / Model: 1692-ZL
• Catalog Number: 1692-ZL
• 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: 7
• Public Version Date: 2021-04-19
• Public Version Status: Update
• Public Device Record Key: d8471f71-805b-464d-80a7-2db79cbf44dd

Device Description

ABSORBABLE COLLAGEN HEMOSTATIC AGENT FIBRILLAR FORM, 0.5GRAM

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	10381780000228	GS1	BOX	5	In Commercial Distribution
Primary	00381780000221	GS1
Secondary	M2691692ZL0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P850010	011

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			0.5 gram

Storage Conditions

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