Catalog Number

8575

Brand Name

TIDI

Version/Model Number

8575

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"

-

For Single-Use

Yes

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

OEA

Product Code Name

Non-Surgical Isolation Gown

Public Device Record Key

3ef46cf8-3e04-4047-abf0-fbb2995f15f9

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 14, 2022

Package DI Number

10618125130020

Quantity per Package

75

Contains DI Package

00618125130023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case