Duns Number:486711679
Device Description: SYNTHECEL® DURA REPAIR 14CM X 20CM (5.5"X 8") STER
Catalog Number
SC40028001S
Brand Name
SyntheCel
Version/Model Number
SC.400.280.01S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K212943
Product Code
GXQ
Product Code Name
DURA SUBSTITUTE
Public Device Record Key
b937995e-bdcc-405f-a31c-4cc0358e960b
Public Version Date
July 18, 2022
Public Version Number
2
DI Record Publish Date
May 26, 2022
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16671 |
| U | Unclassified | 2 |