Duns Number:809555139
Device Description: Utrata Capsulorrhexis Forceps, Very Delicate with line markings at 2.5 and 5.0mm, Angled 1 Utrata Capsulorrhexis Forceps, Very Delicate with line markings at 2.5 and 5.0mm, Angled 12mm from bend to tip with extremely thin triangular grasping tips, flat handle with hole pattern, 90mm total length, Stainless
Catalog Number
F608S-A
Brand Name
Diamatrix Ltd.
Version/Model Number
F608S-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
1ebb1ef6-ce80-4d72-ac8f-2dbdc9818333
Public Version Date
May 20, 2022
Public Version Number
1
DI Record Publish Date
May 12, 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 |