Duns Number:809555139
Device Description: Lu-Mendez Degree Gauge and Fixation Ring, Marked in 10 Degree Increments, Conical Micro-Te Lu-Mendez Degree Gauge and Fixation Ring, Marked in 10 Degree Increments, Conical Micro-Teeth on Bottom of Ring, Stainless Steel.
Catalog Number
M 24125-1
Brand Name
Diamatrix
Version/Model Number
M 24125-1
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
7b92e6f1-24e0-4e66-be82-2830701534c8
Public Version Date
July 10, 2020
Public Version Number
1
DI Record Publish Date
July 02, 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 |