Duns Number:432066322
Device Description: Tibial Headed Screw Dia. 2.5 mm x L. 20 mm
Catalog Number
9095.11.G20
Brand Name
PHYSICA system
Version/Model Number
9095.11.G20
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
b6570d37-42f9-4619-b17c-8b8fd98cde3d
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
September 21, 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 | 595 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3634 |