Duns Number:794759212
Device Description: SILICON HOLDING CLAMP 5MM
Catalog Number
-
Brand Name
BAHADIR USA
Version/Model Number
Y855.02
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"
-
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
K131407
Product Code
FSM
Product Code Name
Tray, Surgical, Instrument
Public Device Record Key
e831bf26-c791-4061-893d-70d8173e41a3
Public Version Date
September 16, 2022
Public Version Number
9
DI Record Publish Date
February 17, 2017
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 | 296 |
2 | A medical device with a moderate to high risk that requires special controls. | 550 |