MatriStem - MicroMatrix, 200 mg - ACELL, INC.

Duns Number:137258252

Device Description: MicroMatrix, 200 mg

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More Product Details

Catalog Number

MM0200

Brand Name

MatriStem

Version/Model Number

MM0200

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KGN

Product Code Name

DRESSING, WOUND, COLLAGEN

Device Record Status

Public Device Record Key

818d51dc-3335-431c-842e-bab6957dbcba

Public Version Date

January 26, 2022

Public Version Number

9

DI Record Publish Date

January 10, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACELL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 91
U Unclassified 62