Duns Number:083171244
Device Description: Omnigraft Kit containing 4cm x4cm Integra® Omnigraft™ Dermal Regeneration Matrix and 1 di Omnigraft Kit containing 4cm x4cm Integra® Omnigraft™ Dermal Regeneration Matrix and 1 disposable skin stapler preloaded with 35 staples
Catalog Number
-
Brand Name
Omnigraft™
Version/Model Number
DFU4041S
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
P900033
Product Code
MDD
Product Code Name
Device, Dermal Replacement
Public Device Record Key
87aa43d7-ff55-4492-bc48-dafc360a28ef
Public Version Date
September 22, 2020
Public Version Number
6
DI Record Publish Date
May 11, 2016
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 | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| 3 | A medical device with high risk that requires premarket approval | 17 |
| U | Unclassified | 32 |