CollaCote®

Basic Information

• Brand Name: CollaCote®
• Primary DI: 10381780000266
• Version / Model: 0101
• Catalog Number: 0101
• 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: 9
• Public Version Date: 2023-04-14
• Public Version Status: Update
• Public Device Record Key: 5b99774a-4aae-4618-bc49-564286ca57c8

Device Description

CollaCote® CollaCote ®Absorbable Collagen Wound Dressing, 3/4in x 1 1/2in

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	30381780000260	GS1	CASE	4	In Commercial Distribution
Primary	10381780000266	GS1
Secondary	H13301011	HIBCC
Unit of Use	00381780000269	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			2 cm x 4 cm
Device Size Text, specify			3/4 in x 1 1/2 in

Storage Conditions

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