Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

82118

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 13, 2022

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NWU

Product Code Name

Endoscope introducer kit

Public Device Record Key

58a0c41c-c6e3-4a42-856c-48906c761371

Public Version Date

July 21, 2022

Public Version Number

1

DI Record Publish Date

July 13, 2022

Package DI Number

20809160376512

Quantity per Package

10

Contains DI Package

10809160376515

Package Discontinue Date

July 13, 2022

Package Status

Not in Commercial Distribution

Package Type

-