Catalog Number

56.12.27P

Brand Name

Synergetics

Version/Model Number

56.12.27P

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

MPA

Product Code Name

Endoilluminator

Public Device Record Key

4ee31168-2c5f-4154-8c6e-20fe22a34b43

Public Version Date

May 07, 2019

Public Version Number

5

DI Record Publish Date

February 23, 2018

Package DI Number

20841305111756

Quantity per Package

12

Contains DI Package

10841305111742

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box