Catalog Number

D2001

Brand Name

Mediflex Suture Passers

Version/Model Number

D2001

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"

Yes

For Single-Use

Yes

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

HCF

Product Code Name

Instrument, Ligature Passing And Knot Tying

Public Device Record Key

ff2be6b9-82b1-44f8-a5f7-7eebad039413

Public Version Date

December 04, 2020

Public Version Number

5

DI Record Publish Date

February 22, 2017

Package DI Number

10842102105095

Quantity per Package

10

Contains DI Package

00842102105098

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case