Duns Number:942377524
Device Description: CAPTURE™ Cannulated Screw SystemThe Reduction Bone Clamp is used to hold and/or compress CAPTURE™ Cannulated Screw SystemThe Reduction Bone Clamp is used to hold and/or compress bone cuts during screw insertion.
Catalog Number
AI1010
Brand Name
CAPTURE™
Version/Model Number
AI-1010
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)
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
a617948d-39d9-4699-97ac-d77d02705823
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 30, 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 | 1909 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1404 |
| 3 | A medical device with high risk that requires premarket approval | 12 |
| U | Unclassified | 15 |