Duns Number:790265227
Device Description: 27 Gauge BB Vitreous Cutter, R4+, w/ 72” Anterior Tubing Set, Sterile, Single Use
Catalog Number
2510BB
Brand Name
Bi-Blade®
Version/Model Number
2510BB
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
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
K153168,K153168
Product Code
HQE
Product Code Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Public Device Record Key
36fc243b-a77d-4616-aeab-ee36042a0e85
Public Version Date
December 17, 2018
Public Version Number
1
DI Record Publish Date
November 16, 2018
Package DI Number
10812480011042
Quantity per Package
6
Contains DI Package
00812480011045
Package Discontinue Date
-
Package Status
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 |