Duns Number:711789789
Device Description: DISPOSABLE GRASPING FORCEPS
Catalog Number
-
Brand Name
DISPOSABLE GRASPING FORCEPS
Version/Model Number
FG-402Q
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"
Yes
For Single-Use
Yes
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
K955063,K955063
Product Code
OCZ
Product Code Name
Endoscopic grasping/cutting instrument, non-powered
Public Device Record Key
8418f5b4-c40c-409f-9e23-272a5f4a3b1b
Public Version Date
November 30, 2021
Public Version Number
5
DI Record Publish Date
September 21, 2016
Package DI Number
14953170143189
Quantity per Package
1
Contains DI Package
04953170143182
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 117 |
2 | A medical device with a moderate to high risk that requires special controls. | 1962 |
U | Unclassified | 52 |