Duns Number:809555139
Device Description: Maloney PRK Spatula, 2mm x 5mm Semi-Sharp spatulated tip, Angled 5mm from bend to tip, Rou Maloney PRK Spatula, 2mm x 5mm Semi-Sharp spatulated tip, Angled 5mm from bend to tip, Round knurled Handle, 120mm total length, Stainless Steel
Catalog Number
H372-S
Brand Name
Diamatrix
Version/Model Number
H372-S
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
208f242d-16a0-4b76-9b3d-309c7ab16833
Public Version Date
September 09, 2020
Public Version Number
1
DI Record Publish Date
September 01, 2020
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 | 475 |
| U | Unclassified | 13 |