Duns Number:055870299
Device Description: Dissector Packer-Dual Ended,Ball And Blunt Ends 17.5cm
Catalog Number
-
Brand Name
ASSI
Version/Model Number
ASSI.ATK250142
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
-
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
GDI
Product Code Name
Dissector, Surgical, General & Plastic Surgery
Public Device Record Key
3d7bc720-ec22-40f1-aff9-9e7034c2f284
Public Version Date
July 06, 2020
Public Version Number
1
DI Record Publish Date
June 26, 2020
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 | 1975 |
2 | A medical device with a moderate to high risk that requires special controls. | 400 |