Duns Number:809555139
Device Description: Akahoshi Universal II Pre-Chopper Forceps, Smooth Spear Pointed Sharp Tip, Straight Shafts Akahoshi Universal II Pre-Chopper Forceps, Smooth Spear Pointed Sharp Tip, Straight Shafts, Reverse Cross-Action, Maximum Tip Opening of 2.5mm while maintaining a Maximum Incision Width of 2.0mm, Smooth Groove Round Handle, 120mm Overall Length, Stainless Steel
Catalog Number
CHOP-57
Brand Name
Diamatrix Ltd
Version/Model Number
CHOP-57
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
HNR
Product Code Name
Forceps, Ophthalmic
Public Device Record Key
cc4a4e01-4d03-4aeb-9b37-f0f0229c64b9
Public Version Date
October 04, 2022
Public Version Number
1
DI Record Publish Date
September 26, 2022
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 |