Duns Number:368715301
Device Description: TorqLoc K-wire Ø0.8 mm, length 300 mm, blunt ends, for 4/5/6 mm interference screw
Catalog Number
OP-II-0830B
Brand Name
TorqLoc Instrument
Version/Model Number
OP-II-0830B
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)
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
0c8d13cc-c704-42a6-aa60-2f817825d84b
Public Version Date
May 28, 2018
Public Version Number
1
DI Record Publish Date
April 25, 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 | 142 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |