Catalog Number

Not Applicable

Brand Name

MedSource Gloves

Version/Model Number

MS-64145

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

PXC

Product Code Name

Personal Protection Kit

Public Device Record Key

cf280203-f015-4f2d-afc9-091c16d10af7

Public Version Date

July 30, 2021

Public Version Number

1

DI Record Publish Date

July 22, 2021

Package DI Number

00816703028612

Quantity per Package

10

Contains DI Package

00816703028605

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case