Catalog Number

-

Brand Name

Mediflex Laparoscopic Instruments - Needle Holders

Version/Model Number

92020-H

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GAD

Product Code Name

Retractor

Public Device Record Key

c1e98a39-cbd0-44b0-824a-d1af85754fa5

Public Version Date

March 04, 2019

Public Version Number

1

DI Record Publish Date

January 31, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-