Duns Number:809555139
Device Description: Thornton Fixation Ring, 13mm swivel head with 7mm cutout opening in front, 10° markings vi Thornton Fixation Ring, 13mm swivel head with 7mm cutout opening in front, 10° markings visible from top of ring, Round handle, 110mm total length, Titanium
Catalog Number
TS13Rx7-10
Brand Name
Diamatrix
Version/Model Number
TS13Rx7-10
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
HMR
Product Code Name
Marker, Ocular
Public Device Record Key
887b2d1e-7880-4874-a041-3571b8b85183
Public Version Date
October 14, 2020
Public Version Number
1
DI Record Publish Date
October 06, 2020
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 | 475 |
| U | Unclassified | 13 |