Duns Number:071595540
Device Description: MINI-AGGRESSOR FORCEPS, 15 DEGREE UP
Catalog Number
31.16333
Brand Name
MINI-AGGRESSOR
Version/Model Number
31.16333
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
GEN
Product Code Name
FORCEPS, GENERAL & PLASTIC SURGERY
Public Device Record Key
2787fa01-b75e-44e7-81ca-0f0a674a92d4
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
October 05, 2021
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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |