Duns Number:711789789
Device Description: FG-45U-1 TRIPOD GRASPING FRCPS
Catalog Number
-
Brand Name
GRASPING FORCEPS
Version/Model Number
FG-45U-1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 01, 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
K962387,K962387
Product Code
FFL
Product Code Name
DISLODGER, STONE, BASKET, URETERAL, METAL
Public Device Record Key
f8e867e1-3e48-49ee-bef4-b85ee247002b
Public Version Date
April 08, 2022
Public Version Number
7
DI Record Publish Date
September 21, 2016
Package DI Number
14953170031677
Quantity per Package
1
Contains DI Package
04953170031670
Package Discontinue Date
April 01, 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 |