Duns Number:041546137
Device Description: Utrata Capsulorhexis Forceps, Cystotome Tips, Curved 11.00 mm Jaws, Round Handle, Length 1 Utrata Capsulorhexis Forceps, Cystotome Tips, Curved 11.00 mm Jaws, Round Handle, Length 110 mm, Stainless Steel
Catalog Number
4-0331S
Brand Name
Rumex
Version/Model Number
4-0331S
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
e3ca46a4-32a2-427e-a403-7233d3e1f264
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 |