Catalog Number

-

Brand Name

Head Harness Disposable

Version/Model Number

10-57004

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

BSJ

Product Code Name

Mask, Gas, Anesthetic

Public Device Record Key

2a537811-b7be-43af-bf45-b83423796436

Public Version Date

October 16, 2018

Public Version Number

1

DI Record Publish Date

September 15, 2018

Package DI Number

30641043570047

Quantity per Package

20

Contains DI Package

10641043570043

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-