Catalog Number

DYKE1012B

Brand Name

Medline Industries, Inc.

Version/Model Number

DYKE1012B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 05, 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

0f2c7d46-af0e-4709-881e-ccb7a5c0c371

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

September 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-