Duns Number:711789789
Device Description: FG-301Q RETRIEVAL BASKET FOR SM STONES 2
Catalog Number
-
Brand Name
GRASPING FORCEPS
Version/Model Number
FG-301Q
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 10, 2022
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
-
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
609101b0-3f9e-46f6-85d4-0451095d982e
Public Version Date
August 11, 2022
Public Version Number
8
DI Record Publish Date
September 21, 2016
Package DI Number
14953170032476
Quantity per Package
1
Contains DI Package
04953170032479
Package Discontinue Date
August 10, 2022
Package Status
Not 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 |