Catalog Number

TIDIFS96-10PK

Brand Name

TIDIShield

Version/Model Number

TIDIFS96-10PK

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)

-

Over the Counter (OTC)

Yes

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

8adc68be-92f3-47f3-bf0c-86c5282e6e49

Public Version Date

October 21, 2022

Public Version Number

1

DI Record Publish Date

October 13, 2022

Package DI Number

10618125189998

Quantity per Package

90

Contains DI Package

00618125189984

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box