Catalog Number

65027E

Brand Name

Synergetics

Version/Model Number

65027E

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

-

Product Code

HQE

Product Code Name

Instrument, vitreous aspiration and cutting, ac-powered

Public Device Record Key

4313addd-f38e-4dd9-a08e-86c0a9d5c519

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

December 23, 2017

Package DI Number

20841305108381

Quantity per Package

6

Contains DI Package

10841305101903

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box