AccessGUDID - DEVICE: MatriStem (00386190000137)

GUDID

Device Identifier (DI) Information

Brand Name: MatriStem
Version or Model: MM0060
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MM0060
Company Name: ACELL, INC.

Primary DI Number: 00386190000137
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 137258252 *Terms of Use

Device Description: MicroMatrix, 60 mg

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Collagen dressing	A sterile, bioabsorbable, collagen protein matrix, animal-derived, designed to provide an occlusive/semi-occlusive cover for a wound, primarily to maintain a clean and moist environment for healing. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, or surgical wounds. It may combine collagen with supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Collagen dressing

A sterile, bioabsorbable, collagen protein matrix, animal-derived, designed to provide an occlusive/semi-occlusive cover for a wound, primarily to maintain a clean and moist environment for healing. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, or surgical wounds. It may combine collagen with supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
KGN	DRESSING, WOUND, COLLAGEN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153754	000
K172399	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

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Storage and Handling
Storage Environment Temperature: between 15 and 35 Degrees Celsius

Clinically Relevant Size

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Size Type Text
Weight: 60 Milligram

Device Record Status

Public Device Record Key: 42d697f5-681e-4213-9f1f-e679a9421867
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 10, 2017