Duns Number:876570990
Device Description: Thornton Fixation Ring: Fixed 13mm x 7mm C Style with 10 Degree Markings, Round Knurled Ha Thornton Fixation Ring: Fixed 13mm x 7mm C Style with 10 Degree Markings, Round Knurled Handle, Stainless Steel
Catalog Number
-
Brand Name
Thornton Fixation Ring
Version/Model Number
5-0129-13
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
4ee46b57-e3ac-4df8-9ed2-4078e65d006c
Public Version Date
June 21, 2022
Public Version Number
1
DI Record Publish Date
June 10, 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 |