Integra® Miltex® HeliTape®

Basic Information

• Brand Name: Integra® Miltex® HeliTape®
• Primary DI: 10381780000280
• Version / Model: 62200
• Catalog Number: 62-200
• Company Name: Integra Lifesciences Corporation
• Labeler DUNS: 083171244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2014-09-11
• Public Version: 11
• Public Version Date: 2023-05-04
• Public Version Status: Update
• Public Device Record Key: 2f2a6645-17df-47ba-86d5-db0ff4d068b1

Device Description

HeliTape ® ABSORBABLE COLLAGEN Wound Dressing, 1in x 3in

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
LPG	Material, Dressing, Surgical, Polylactic Acid	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
47184	General oral wound dressing, animal-derived	A collagen protein matrix derived from animal products (e.g., porcine, bovine) intended to be used as a protective cover for the general oral mucosa to manage wounds and sores in the mouth such as ulcers (non-infected or viral), periodontal surgical wounds, suture sites, burns, extraction sites, surgical wounds, and traumatic wounds; it may in addition, or alternatively, be intended to treat mucosal irritations/inflammation, dryness, and/or gingivitis. It may be supplied in various forms (e.g., gel, paste, fluid, water/oil spray solution) for use in the home or a clinical setting. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30381780000284	GS1	CASE	4	In Commercial Distribution
Primary	10381780000280	GS1
Secondary	H834622001	HIBCC
Unit of Use	00381780000283	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			2.5 cm x 7.5 cm
Device Size Text, specify			1 in x 3 in

Storage Conditions

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