Catalog Number

8268.27S

Brand Name

27G Ultra Short Disposable 8000 CPM TDC cutter

Version/Model Number

8268.27S

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

K190875,K190875

Product Code

HQE

Product Code Name

Instrument, Vitreous Aspiration And Cutting, Ac-Powered

Public Device Record Key

482ef8ad-a93c-41e4-bef9-d22221578bec

Public Version Date

March 19, 2020

Public Version Number

2

DI Record Publish Date

June 04, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-