Duns Number:809555139
Device Description: Buratto Lasik Flap Forceps, .8mm very delicate Disc-Shaped tip with serrated jaws, Vaulted Buratto Lasik Flap Forceps, .8mm very delicate Disc-Shaped tip with serrated jaws, Vaulted Shafts, flat handle with hole pattern, 102mm total length, Stainless
Catalog Number
F942S
Brand Name
Diamatrix Ltd.
Version/Model Number
F942S
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
68715282-6845-473c-b548-61336e5c52a3
Public Version Date
June 17, 2022
Public Version Number
1
DI Record Publish Date
June 09, 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 |