Duns Number:809555139
Device Description: Nagahara Karate Chopper, 1.5mm, Centered interior cutting edge with Bullet-Shaped tip, Ang Nagahara Karate Chopper, 1.5mm, Centered interior cutting edge with Bullet-Shaped tip, Angled 10mm from bend to tip, Round knurled Handled, 113mm total length, Stainless Steel.
Catalog Number
H435-S
Brand Name
Diamatrix Ltd.
Version/Model Number
H435-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
ad9170c0-c2c9-41ca-a9a5-745b44f269f6
Public Version Date
July 30, 2021
Public Version Number
1
DI Record Publish Date
July 22, 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 |