Catalog Number

-

Brand Name

wellead

Version/Model Number

10-0048

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

-

Product Code

OGP

Product Code Name

Cricothyrotomy Kit

Public Device Record Key

05a21fb6-0f5c-47a8-8401-15f0bad9bd37

Public Version Date

October 25, 2021

Public Version Number

1

DI Record Publish Date

October 15, 2021

Package DI Number

16944932791876

Quantity per Package

10

Contains DI Package

06944932791879

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box