Duns Number:315304071
Device Description: FLEX. GRASP. FORCEPS 3FR WL 230MM fine-toothed, double action, TL 380mm, non-dismantling, FLEX. GRASP. FORCEPS 3FR WL 230MM fine-toothed, double action, TL 380mm, non-dismantling, reusable
Catalog Number
828.03
Brand Name
NA
Version/Model Number
82803
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
FCL
Product Code Name
FORCEPS, BIOPSY, NON-ELECTRIC
Public Device Record Key
3d9f9eb3-8477-4181-96a2-f495684c4adf
Public Version Date
August 03, 2022
Public Version Number
7
DI Record Publish Date
September 27, 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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |