Duns Number:809555139
Device Description: Utrata Capsulorhexis Forceps, Very Delicate, Angled 11mm from bend to tip with extremely t Utrata Capsulorhexis Forceps, Very Delicate, Angled 11mm from bend to tip with extremely thin triangular grasping tips, Diamond knurled handle, Guide pin stop for tip alignment, 105mm total length, Stainless
Catalog Number
F612S-A
Brand Name
Diamatrix
Version/Model Number
F612S-A
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
6a86e148-3535-4ed9-92ba-53ecb167c2b9
Public Version Date
June 18, 2021
Public Version Number
1
DI Record Publish Date
June 10, 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 |