Catalog Number

221011K

Brand Name

TIDI

Version/Model Number

221011K

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

c0b81ec1-5c3d-473e-b1e5-0a264dbf2ed5

Public Version Date

October 20, 2022

Public Version Number

1

DI Record Publish Date

October 12, 2022

Package DI Number

10618125189929

Quantity per Package

100

Contains DI Package

00618125189922

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box