Duns Number:837845234
Device Description: Orthopedic surgical instrument - Guide tube
Catalog Number
GTT2-000
Brand Name
PRECICE® Instruments
Version/Model Number
GTT2-000
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
K172061
Product Code
HSB
Product Code Name
Rod, Fixation, Intramedullary And Accessories
Public Device Record Key
6108ef3e-26bc-4926-ab11-cf565d2241c9
Public Version Date
April 06, 2020
Public Version Number
5
DI Record Publish Date
January 02, 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 | 254 |
2 | A medical device with a moderate to high risk that requires special controls. | 2199 |