Duns Number:832696038
Device Description: SINSKEY II LENS MANIPULATING HOOK, STRAIGHT WITH GUARD, .2MM DIAMTER BLUNT TIP, ROUND HAND SINSKEY II LENS MANIPULATING HOOK, STRAIGHT WITH GUARD, .2MM DIAMTER BLUNT TIP, ROUND HANDLE
Catalog Number
OP0923-304
Brand Name
V. Mueller
Version/Model Number
OP0923-304
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
5a9aa381-8b39-42a1-a5e9-4f88f55d3396
Public Version Date
February 24, 2020
Public Version Number
2
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 |