Duns Number:041546137
Device Description: Whitehouse Gravity Axis Marker, Angled, Marks At 3, 6, 9 o'clock, 11.00/14.00mm, Length 15 Whitehouse Gravity Axis Marker, Angled, Marks At 3, 6, 9 o'clock, 11.00/14.00mm, Length 153 mm, Round Titanium Handle, Stainless Steel Gravity System
Catalog Number
3-193
Brand Name
Rumex
Version/Model Number
3-193
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)
-
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
f252df9a-ee80-437c-aa71-2e9d7c6ac158
Public Version Date
June 10, 2020
Public Version Number
1
DI Record Publish Date
June 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 | 834 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |