Duns Number:809555139
Device Description: Koch Stop and Chop Manipulator, .33mm x 1.5mm long tip design, Angled 10mm from bend to ti Koch Stop and Chop Manipulator, .33mm x 1.5mm long tip design, Angled 10mm from bend to tip, Round knurled Handle, 118mm total length, Stainless Steel.
Catalog Number
H320-10-S
Brand Name
Diamatrix Ltd
Version/Model Number
H320-10-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
8836fd43-d4b1-48e1-bcb3-2f6e7021bb24
Public Version Date
August 20, 2021
Public Version Number
1
DI Record Publish Date
August 12, 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 |