Duns Number:348489386
Device Description: The 11 distal (blue handle) and 11 proximal (whithe handle) rasps are device specific inst The 11 distal (blue handle) and 11 proximal (whithe handle) rasps are device specific instruments used to create bone cavities for the implantation of the Osteotec Silicone Finger Implant. Each rasp is dedicated to a particular size of implant and is based on the design of the proximal or distal stem.
Catalog Number
OSTF-9D
Brand Name
Osteotec Silicone Finger - Distal Rasp Size 9
Version/Model Number
OSTF-9D
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
HTQ
Product Code Name
Broach
Public Device Record Key
fc384a58-63fb-4a58-abd9-100324337963
Public Version Date
June 10, 2022
Public Version Number
2
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 |