Duns Number:832696038
Device Description: V. Mueller SIMCOE NUCLEUS SPATULA 25GA
Catalog Number
OP20621
Brand Name
V. Mueller
Version/Model Number
OP20621
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 15, 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
HND
Product Code Name
Spatula, ophthalmic
Public Device Record Key
634b121c-1ad2-4c60-b40e-728f8633733a
Public Version Date
March 07, 2022
Public Version Number
5
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 |