Duns Number:809555139
Device Description: Castroviejo Cyclodialysis, Unique double sided instrument, Spatula, .5mm flat posterior su Castroviejo Cyclodialysis, Unique double sided instrument, Spatula, .5mm flat posterior surface with Semi-Sharp tip, Angled/Vaulted 10mm from bend to tip / .5mm flat posterior surface with Semi-Sharp tip, Angled/Vaulted 15mm from bend to tip, Flat handle, 135mm total length.
Catalog Number
-
Brand Name
Diamatrix Ltd
Version/Model Number
H380-.5
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
57c15972-3cc9-4ff8-9527-ab4f1db08c6c
Public Version Date
August 27, 2021
Public Version Number
1
DI Record Publish Date
August 19, 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 |