DEVICE: MatriStem (00386190000786)
Device Identifier (DI) Information
MatriStem
BMM1015
Not in Commercial Distribution
BMM1015
ACELL, INC.
BMM1015
Not in Commercial Distribution
BMM1015
ACELL, INC.
Burn Matrix Meshed 10X15cm
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
45023 | Animal-derived wound matrix dressing |
A bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KGN | DRESSING, WOUND, COLLAGEN |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 15 and 35 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Rectangle device approximately 10 x 15 cm |
Device Record Status
c8c27fed-fd68-41ea-b75c-e294ce495c2b
July 21, 2025
10
January 10, 2017
July 21, 2025
10
January 10, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)826-2926
customerservice@acell.com
customerservice@acell.com