Duns Number:041546137
Device Description: Capsulorhexis Forceps With Scale (2.5 mm, 5.0 mm From The Tip), Cross Action, Straight Sta Capsulorhexis Forceps With Scale (2.5 mm, 5.0 mm From The Tip), Cross Action, Straight Stainless Steel Jaws 8.5 mm, For 1.5 mm Incisions, Length 110 mm, Flat Titanium Handle
Catalog Number
4-0396
Brand Name
Rumex
Version/Model Number
4-0396
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)
-
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
05b77be7-5f94-4a27-91b2-2dbf9e3b9f59
Public Version Date
August 04, 2020
Public Version Number
1
DI Record Publish Date
July 27, 2020
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 | 834 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |