Duns Number:348489386
Device Description: The Osteotec Silicone Finger Implant Sizer is a one-piece, blue flexible silicone elastome The Osteotec Silicone Finger Implant Sizer is a one-piece, blue flexible silicone elastomer device with the same dimensions as the Osteotec Silicone Finger Implant. The sizers are used initially as a guide to choosing the correct size of implant and then, once that choice is made, to insert into the prepared joint space to enable the surgeon to check fit and function e.g. range of motion
Catalog Number
OSTF-S1
Brand Name
Osteotec Silicone Finger Implant Sizer Size 1
Version/Model Number
OSTF-S1
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
HWT
Product Code Name
Template
Public Device Record Key
f420e1bf-9718-4623-a53c-675e9ba8e40a
Public Version Date
February 14, 2022
Public Version Number
1
DI Record Publish Date
February 04, 2022
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 | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |