Duns Number:832696038
Device Description: OLK ANGLED RETINAL SPATULA, TRIANGULAR .5MM TIP ANGLED 150°, 4MM FLAT SURFACE, ROUND, KNUR OLK ANGLED RETINAL SPATULA, TRIANGULAR .5MM TIP ANGLED 150°, 4MM FLAT SURFACE, ROUND, KNURLED HANDLE
Catalog Number
OP0924-002
Brand Name
V. Mueller
Version/Model Number
OP0924-002
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 01, 2018
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
HND
Product Code Name
Spatula, ophthalmic
Public Device Record Key
0a9e11fb-dbc5-41b7-bd9f-666b255fd763
Public Version Date
February 24, 2020
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 |