Duns Number:809555139
Device Description: Sinskey II Lens Manipulating Hook .2mm Diameter blunt tip, Straight Shaft, Standard flat h Sinskey II Lens Manipulating Hook .2mm Diameter blunt tip, Straight Shaft, Standard flat handle, 120mm total length.
Catalog Number
H101FS-S
Brand Name
Diamatrix Ltd.
Version/Model Number
H101FS-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
d60bba3d-913c-4401-a793-2f6c415a0bde
Public Version Date
August 06, 2021
Public Version Number
1
DI Record Publish Date
July 29, 2021
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 |