Duns Number:832696038
Device Description: THORNTON LOW PROFILE MARKER, 4.0MM LONG RADIAL LINES, INNER DIAMETER OF BLADES 4.5MM, 8 LI THORNTON LOW PROFILE MARKER, 4.0MM LONG RADIAL LINES, INNER DIAMETER OF BLADES 4.5MM, 8 LINES
Catalog Number
OP0925-403
Brand Name
V. Mueller
Version/Model Number
OP0925-403
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
2ddd8731-a35e-45ad-a9c8-319953625a9a
Public Version Date
October 08, 2018
Public Version Number
1
DI Record Publish Date
September 07, 2018
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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |