Duns Number:315018218
Device Description: ADTEC MONOPOLAR Biopsy Forceps, complete instrument, (420 mm), diam. 5 mm, serrated, singl ADTEC MONOPOLAR Biopsy Forceps, complete instrument, (420 mm), diam. 5 mm, serrated, single action, consisting of PM981R, PO756R, PO958R, reusable
Catalog Number
PO511R
Brand Name
AESCULAP
Version/Model Number
PO511R
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
b2bd7dcd-750b-4dcc-a8e0-e19a3b92fb10
Public Version Date
October 13, 2021
Public Version Number
4
DI Record Publish Date
September 23, 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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |