Duns Number:809555139
Device Description: Chang Microfinger Chopper & Diamatrix Vertical Safety Chopper, Unique double-sided instrum Chang Microfinger Chopper & Diamatrix Vertical Safety Chopper, Unique double-sided instrument, Chang Microfinger Chopper, Unique C-Shaped Chopper with blunt tip, Intended to be used in the Left hand / Vertical Safety Chopper, .5mm Olive-Shaped Blade with 1mm bend, Both sides Angled 10mm from bend to tip, Round knurled Handle, 142mm total length, Stainless Steel
Catalog Number
H582-L-S
Brand Name
Diamatrix
Version/Model Number
H582-L-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
656985c5-aa3a-46b7-8265-cc93b52de90f
Public Version Date
December 21, 2020
Public Version Number
1
DI Record Publish Date
December 12, 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 |