Duns Number:604056226
Device Description: Swinging Biopsy Forceps, Oval Cup without Spike, 2.4mm Diam, 2300mm L
Catalog Number
-
Brand Name
Key Surgical Biopsy Forceps
Version/Model Number
EN10272AS
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
Yes
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
61dbaced-250d-4089-8eb0-d229405abe69
Public Version Date
September 08, 2021
Public Version Number
4
DI Record Publish Date
February 18, 2020
Package DI Number
00849771038900
Quantity per Package
10
Contains DI Package
00849771038894
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 326 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 219 |