Duns Number:303456917
Device Description: Clamping Bolt, Distal Femur a. Tibia
Catalog Number
118003-13
Brand Name
Clamping Bolt
Version/Model Number
118003-13
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
baf05c85-3e00-4a60-a9f0-be0b1813e97c
Public Version Date
November 19, 2018
Public Version Number
1
DI Record Publish Date
October 18, 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 | 410 |
2 | A medical device with a moderate to high risk that requires special controls. | 1463 |