Duns Number:594540572
Device Description: Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine colla Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.
Catalog Number
-
Brand Name
Myriad Morcells™
Version/Model Number
PW01NA1000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
Yes
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
K200502
Product Code
KGN
Product Code Name
Dressing, Wound, Collagen
Public Device Record Key
5766ee74-69df-4b7b-a041-4617a5f4c0c3
Public Version Date
January 07, 2022
Public Version Number
2
DI Record Publish Date
April 12, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 135 |
| U | Unclassified | 33 |