Duns Number:832696038
Device Description: V. Mueller SIMCOE NUCLEUS LOOP LEFT & RIGHT LOOPS, DBL-END 20 X 4MM WIDE, ROUND KNURLED HN V. Mueller SIMCOE NUCLEUS LOOP LEFT & RIGHT LOOPS, DBL-END 20 X 4MM WIDE, ROUND KNURLED HNDL OVERALL LENGTH 5-1/2" (14CM)
Catalog Number
OP1850
Brand Name
V. Mueller
Version/Model Number
OP1850
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 22, 2021
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
HNB
Product Code Name
Spoon, ophthalmic
Public Device Record Key
1104691b-c833-40f6-90b8-2b48e21d3bab
Public Version Date
March 07, 2022
Public Version Number
3
DI Record Publish Date
December 27, 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 |