Duns Number:041546137
Device Description: Irrigation Handpiece For Bimanual Technique, Curved, 21 Ga, Two Ports On Side 0.50 mm, Len Irrigation Handpiece For Bimanual Technique, Curved, 21 Ga, Two Ports On Side 0.50 mm, Length 104 mm, Titanium Handle
Catalog Number
7-0813
Brand Name
Rumex
Version/Model Number
7-0813
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
KYG
Product Code Name
Device, Irrigation, Ocular Surgery
Public Device Record Key
cc650a74-6582-49ec-af25-8ca408f9c0ee
Public Version Date
June 16, 2020
Public Version Number
1
DI Record Publish Date
June 08, 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 |