DEVICE: MicroMatrix® (00386190001196)
Device Identifier (DI) Information
MicroMatrix®
MM0200F
In Commercial Distribution
MM0200F
ACELL, INC.
MM0200F
In Commercial Distribution
MM0200F
ACELL, INC.
MicroMatrix, 200 mg Fine Particulate
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KGN | DRESSING, WOUND, COLLAGEN |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K153754 | 000 |
K172399 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in a clean, dry environment at room temperature |
Clinically Relevant Size
[?]Size Type Text |
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Weight: 200 Milligram |
Device Record Status
bdf1b9eb-0288-4de0-a36b-3add4471c905
July 06, 2018
3
January 20, 2017
July 06, 2018
3
January 20, 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 |
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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