Duns Number:536935331
Device Description: The axial compression clamp is used to allow a compression and is used with the 115425ND K The axial compression clamp is used to allow a compression and is used with the 115425ND K-Wire.
Catalog Number
-
Brand Name
SURFIX®
Version/Model Number
219900ND
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"
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
HXD
Product Code Name
CLAMP
Public Device Record Key
0a2ebdf4-edb9-42f2-b244-42c1995d409e
Public Version Date
August 21, 2019
Public Version Number
5
DI Record Publish Date
May 31, 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 | 388 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 235 |