Duns Number:832696038
Device Description: GILLS-WELSH LENS LOOP 7 X 5MM WIDE THIN LOOP OLIVE TIP ON OPPOSITE END OVERALL LENGTH 4-3/ GILLS-WELSH LENS LOOP 7 X 5MM WIDE THIN LOOP OLIVE TIP ON OPPOSITE END OVERALL LENGTH 4-3/4"(12.1CM)
Catalog Number
OP9301
Brand Name
V. Mueller
Version/Model Number
OP9301
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
HMX
Product Code Name
Cannula, ophthalmic
Public Device Record Key
d9a173d9-cbce-4b80-8696-e5ce4c9b0133
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 |