Duns Number:809555139
Device Description: Mendez Degree Gauge with malleable shaft, Outside Diameter 16mm, Inside Diameter 12mm, Rul Mendez Degree Gauge with malleable shaft, Outside Diameter 16mm, Inside Diameter 12mm, Ruler markings on top of ring in 5° Increments, Diamond knurled handle, 118mm total length, Stainless
Catalog Number
M30S
Brand Name
Diamatrix
Version/Model Number
M30S
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
02b6c456-1804-4b49-aa81-43ebd20fff45
Public Version Date
July 02, 2021
Public Version Number
1
DI Record Publish Date
June 24, 2021
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 |