Catalog Number

-

Brand Name

CLEARLITE, ANAESTHETIC FACE MASK, SIZE 4, MEDIUM ADULT, GREEN SEAL, 22F

Version/Model Number

7294000

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

c8834157-9f93-4c11-9a14-076186a4fd89

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

October 25, 2021

Package DI Number

05030267153305

Quantity per Package

35

Contains DI Package

05030267152278

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-