Catalog Number

UL-0378S-05

Brand Name

TSI

Version/Model Number

UL-0378S

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MDM

Product Code Name

Instrument, Manual, Surgical, General Use

Public Device Record Key

784cbd8b-2a9a-4aea-9e50-4d77760882c3

Public Version Date

July 25, 2022

Public Version Number

1

DI Record Publish Date

July 15, 2022

Package DI Number

10843059126065

Quantity per Package

5

Contains DI Package

00843059126068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box