Duns Number:790265227
Device Description: 27 Gauge Vitreous Cutter, R4, w/ 79” CPC Tubing Set, Sterile, Single Use
Catalog Number
2960CE
Brand Name
NA
Version/Model Number
2960CE
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 02, 2019
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
Yes
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
K102222,K102222
Product Code
HQE
Product Code Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Public Device Record Key
97440fb3-163e-4c08-b248-b10fe5cfbf10
Public Version Date
November 12, 2020
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
10812480010366
Quantity per Package
6
Contains DI Package
00812480010369
Package Discontinue Date
October 02, 2019
Package Status
Not in Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 30 |