Duns Number:942377524
Device Description: CAPTURE™ High Torque Screw SystemThe trocar pin sleeve is used during guide pin placement CAPTURE™ High Torque Screw SystemThe trocar pin sleeve is used during guide pin placement in the Capture high torque screw system.
Catalog Number
PS5000501070
Brand Name
CAPTURE™
Version/Model Number
TPS-5000-501-070
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
LXH
Product Code Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Public Device Record Key
a241ea92-0d91-4529-bd94-cd3d75ea7666
Public Version Date
April 06, 2020
Public Version Number
4
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 |