Duns Number:015108087
Device Description: College Plier Serr German
Catalog Number
-
Brand Name
BENCO
Version/Model Number
5094-202
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HTC
Product Code Name
Pliers, Surgical
Public Device Record Key
f5242e8d-f38f-4a7f-ab7f-d0b7e967a9bd
Public Version Date
December 21, 2018
Public Version Number
2
DI Record Publish Date
October 31, 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 | 1364 |
2 | A medical device with a moderate to high risk that requires special controls. | 377 |
U | Unclassified | 15 |