Duns Number:342243334
Device Description: Flexible grasping forceps. w. alligator jaw, Ø1.6mm/5Fr., 600mm
Catalog Number
35.010.215
Brand Name
Flexible grasping forceps. w. alligator jaw, Ø1.6mm/5Fr., 600mm
Version/Model Number
35.010.215
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
c2b68261-9847-4e9a-a17d-274bc72ef44d
Public Version Date
August 21, 2019
Public Version Number
3
DI Record Publish Date
August 03, 2016
Package DI Number
EMAH350102151
Quantity per Package
1
Contains DI Package
EMAH350102150
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 | 19 |
2 | A medical device with a moderate to high risk that requires special controls. | 1976 |