AccessGUDID - DEVICE: INTEGRA Bilayer Matrix Wound Dressing (10381780032250)

GUDID

Device Identifier (DI) Information

Brand Name: INTEGRA Bilayer Matrix Wound Dressing
Version or Model: BMW405
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BMW405
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780032250
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: INTEGRA Bilayer Matrix Wound Dressing is an advanced woundcare device comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan and a semi-permeable polysiloxane (silicone) layer. The semi-permeable silicone membrane controls water vapor loss, provides a flexible adherent covering for the wound surface and adds increased tear strength to the device. The collagen-glycosaminoglycan biodegradable matrix provides a scaffold for cellular invasion and capillary growth.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, wound, drug
KGN	Dressing, wound, collagen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K021792	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store Flat
Handling Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 4 Inch
Width: 10 Centimeter
Length: 12.5 Centimeter
Length: 5 Inch

Device Record Status

Public Device Record Key: 3f88f10a-a668-4b2d-ad56-b4fe789a4cbf
Public Version Date: September 22, 2020
Public Version Number: 6
DI Record Publish Date: September 23, 2015