Integra® Dermal Regeneration Template

Basic Information

• Brand Name: Integra® Dermal Regeneration Template
• Primary DI: 10381780000600
• Version / Model: 38101
• Catalog Number: 38101
• Company Name: Integra Lifesciences Corporation
• Labeler DUNS: 083171244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-05
• Public Version: 8
• Public Version Date: 2023-04-20
• Public Version Status: Update
• Public Device Record Key: ea03f588-03b2-4ce8-b256-dca6b201394c

Device Description

Integra® Dermal Regeneration Template 8in. x 10in. (20cm x 25cm)

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
MGR	Dressing, Wound And Burn, Interactive	Unknown		3
MDD	Device, dermal replacement	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
Secondary	M269381011	HIBCC
Primary	10381780000600	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P900033	011

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			8 in x 10 in

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store Flat
• Type: Handling Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius