Catalog Number

-

Brand Name

Head Harness Disposable

Version/Model Number

10-57005

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 23, 2021

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

c3741f74-cea9-492e-82b9-538230b9c1ba

Public Version Date

September 24, 2021

Public Version Number

2

DI Record Publish Date

September 15, 2018

Package DI Number

30641043570054

Quantity per Package

1

Contains DI Package

10641043570050

Package Discontinue Date

September 23, 2021

Package Status

Not in Commercial Distribution

Package Type

-