Catalog Number

-

Brand Name

Wellead

Version/Model Number

U04D020110

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

K211814,K211814,K211814

Product Code

ODC

Product Code Name

Endoscope Channel Accessory

Public Device Record Key

42dfceef-1018-4778-a7d5-d628a5795405

Public Version Date

February 03, 2022

Public Version Number

1

DI Record Publish Date

January 26, 2022

Package DI Number

16944932785127

Quantity per Package

10

Contains DI Package

06944932785120

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton