Catalog Number

3706-ST

Brand Name

WeL® ORTHO-SUCTION TUBE

Version/Model Number

3706, Sterile

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

JOL

Product Code Name

Catheter And Tip, Suction

Public Device Record Key

b19b56bb-bb80-472f-bd3a-6fa919c5e725

Public Version Date

August 06, 2021

Public Version Number

1

DI Record Publish Date

July 29, 2021

Package DI Number

M7243706ST2

Quantity per Package

50

Contains DI Package

M7243706ST1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box