Duns Number:809555139
Device Description: Machat Lasik Retreatment Spatula, Unique double sided instrument, Cylindrical Spatula with Machat Lasik Retreatment Spatula, Unique double sided instrument, Cylindrical Spatula with Slightly Pointed tip, Angled 8mm from bend to tip ~ .8mm wide spatula, Flat inferior edge with rounded front tip, Angled 1.2mm from bend to tip, Round knurled Handle, 120mm total length, Stainless Steel
Catalog Number
H558-S
Brand Name
Diamatrix Ltd.
Version/Model Number
H558-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
05d3e9a4-e181-4061-b6fc-2350a7d0c7c8
Public Version Date
November 15, 2021
Public Version Number
1
DI Record Publish Date
November 05, 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 |