Duns Number:832696038
Device Description: KUGLEN IRIS HOOK & LENS MANIPULATOR, PUSH-PULL MODEL CLOVERLEAF TIP OVERALL LENGTH 4-1/2"( KUGLEN IRIS HOOK & LENS MANIPULATOR, PUSH-PULL MODEL CLOVERLEAF TIP OVERALL LENGTH 4-1/2"(11.4CM)
Catalog Number
OP2504
Brand Name
V. Mueller
Version/Model Number
OP2504
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
e5cc18e2-bf73-4ad0-9575-b71e5504ca94
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 |