Catalog Number

-

Brand Name

TIGER MEDICAL FULL FACE SHIELD

Version/Model Number

FFC101

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

a496e92a-1d0e-42d7-9175-9d4c5b9182b8

Public Version Date

July 11, 2022

Public Version Number

1

DI Record Publish Date

July 01, 2022

Package DI Number

10840216100937

Quantity per Package

24

Contains DI Package

00840216100930

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack