Duns Number:876570990
Device Description: Fine-Thornton swivel fixation ring, 5 1/4", C-shaped 13mm diameter swivel head with 7mm cu Fine-Thornton swivel fixation ring, 5 1/4", C-shaped 13mm diameter swivel head with 7mm cut-out, flat handle, stainless steel
Catalog Number
-
Brand Name
Fine Thornton Fixation Ring
Version/Model Number
12-25050
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
HMR
Product Code Name
Marker, Ocular
Public Device Record Key
13620134-710e-4b11-8059-be85f3704c5c
Public Version Date
March 04, 2022
Public Version Number
1
DI Record Publish Date
February 24, 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 | 120 |