Catalog Number

12.06.27

Brand Name

Synergetics

Version/Model Number

12.06.27

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

MDM

Product Code Name

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Public Device Record Key

9de9661c-dd27-4479-a2b9-099f0d3c19a8

Public Version Date

October 07, 2019

Public Version Number

6

DI Record Publish Date

September 01, 2017

Package DI Number

20841305110636

Quantity per Package

6

Contains DI Package

10841305110622

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box