Duns Number:040729840
Device Description: GRASPING RONGUER BIOPSY FORCEPS SERRATED 3.4 MILLIMETER CUP TUBULAR SHAFT 4.0 INCHES
Catalog Number
1271-018
Brand Name
ARTHROSCOPIC GRASPING & BIOPSY RONGEUR FORCEPS
Version/Model Number
1271-018
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
FCL
Product Code Name
FORCEPS, BIOPSY, NON-ELECTRIC
Public Device Record Key
fe88ad9c-253b-4aa9-bf3e-8724eebb5be8
Public Version Date
November 04, 2020
Public Version Number
5
DI Record Publish Date
September 11, 2018
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 | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |