Duns Number:055870299
Device Description: DeBakey Tissue Forceps Atraumatic 20 cm Angled, 2mm tip, Insulated to 1cm from the bend, f DeBakey Tissue Forceps Atraumatic 20 cm Angled, 2mm tip, Insulated to 1cm from the bend, for monopolar use
Catalog Number
-
Brand Name
ASSI
Version/Model Number
ASSI.AG7062226
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
GEN
Product Code Name
Forceps, General & Plastic Surgery
Public Device Record Key
bdae61e7-00fe-432a-b81d-e4a5f407f1ae
Public Version Date
July 20, 2020
Public Version Number
1
DI Record Publish Date
July 10, 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 |