Catalog Number

85-4332

Brand Name

MED-RX

Version/Model Number

85-4332

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

MCZ

Product Code Name

Suture Removal Kit

Public Device Record Key

b55de107-cd3e-4dec-b0f5-d8f05e5d786d

Public Version Date

May 29, 2020

Public Version Number

1

DI Record Publish Date

May 21, 2020

Package DI Number

50628725044243

Quantity per Package

50

Contains DI Package

00628725044248

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton