Catalog Number

2390BB

Brand Name

Bi-Blade®

Version/Model Number

2390BB

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

610ade5c-b97a-4d33-baba-f964ca987a50

Public Version Date

December 17, 2018

Public Version Number

1

DI Record Publish Date

November 16, 2018

Package DI Number

10812480011028

Quantity per Package

6

Contains DI Package

00812480011021

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton