Duns Number:832696038
Device Description: MANSON DOUBLE ENDED HOOK, 3MM FORKED ANGLED BLADES, BLADE SPREAD 7MM, FLAT, SERRATED HANDL MANSON DOUBLE ENDED HOOK, 3MM FORKED ANGLED BLADES, BLADE SPREAD 7MM, FLAT, SERRATED HANDLE
Catalog Number
OP0924-651
Brand Name
V. Mueller
Version/Model Number
OP0924-651
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
HNQ
Product Code Name
Hook, ophthalmic
Public Device Record Key
35c30cc9-aaba-43ae-95b8-6e8de4db0983
Public Version Date
June 08, 2021
Public Version Number
3
DI Record Publish Date
September 05, 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 |