Catalog Number

-

Brand Name

Disconnect Wedge

Version/Model Number

10-55340

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

-

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

BYX

Product Code Name

Tubing, Pressure And Accessories

Public Device Record Key

1ab3d895-a4b0-45f4-a443-540548eb2a68

Public Version Date

June 02, 2021

Public Version Number

1

DI Record Publish Date

May 25, 2021

Package DI Number

30641043553408

Quantity per Package

50

Contains DI Package

10641043553404

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-