ORACOTE®

Basic Information

• Brand Name: ORACOTE®
• Primary DI: 10381780000310
• Version / Model: #ORACOTE-PKG-10
• Catalog Number: #ORACOTE-PKG-10
• Company Name: Integra Lifesciences Corporation
• Labeler DUNS: 083171244
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2014-09-11
• Public Version: 8
• Public Version Date: 2021-04-19
• Public Version Status: Update
• Public Device Record Key: f0393dc7-8f04-4c72-8b5a-1b3507885be2
• Distribution End Date: 2020-03-31

Device Description

SALVIN OraCOTE® Absorbable Collagen Wound Dressing for Dental Surgery, 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
45023	Collagen wound matrix dressing	A sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30381780000314	GS1	CASE	4	Not in Commercial Distribution	2020-03-31
Primary	10381780000310	GS1
Secondary	M268ORACOTEPKG101	HIBCC
Unit of Use	00381780000313	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