Duns Number:132418851
Device Description: Angel Processing Sets (EU) Case of 8 Kits or 8 Trays with 016342 Case Label EU Processing Angel Processing Sets (EU) Case of 8 Kits or 8 Trays with 016342 Case Label EU Processing Set
Catalog Number
-
Brand Name
Angel Processing Sets (EU)
Version/Model Number
976000601
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
a8a3f0e4-e3f5-431f-8785-07e7a7f8c17a
Public Version Date
January 08, 2021
Public Version Number
3
DI Record Publish Date
September 19, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 8 |