Duns Number:832696038
Device Description: NEW ORLEANS LENS LOOP LONG OVAL, VERY LIGHT 10 X 5MM WIDE LOOP OVERALL LENGTH 5-1/4"(13.3C NEW ORLEANS LENS LOOP LONG OVAL, VERY LIGHT 10 X 5MM WIDE LOOP OVERALL LENGTH 5-1/4"(13.3CM)
Catalog Number
OP2177
Brand Name
V. Mueller
Version/Model Number
OP2177
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
HNB
Product Code Name
Spoon, ophthalmic
Public Device Record Key
52c45b83-7230-41e1-9f46-66d1d6e44fdc
Public Version Date
October 07, 2019
Public Version Number
2
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 |