Catalog Number

-

Brand Name

Moore Medical

Version/Model Number

83030

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

MCY

Product Code Name

Kit, Wound Dressing

Public Device Record Key

649e6e2e-7490-402e-a096-c680ef10ae9b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 09, 2016

Package DI Number

40607415001622

Quantity per Package

20

Contains DI Package

10607415001614

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case