Tools - FPS - Universal Hook Plt, 5-Hole, Template - TRIMED, INCORPORATED

Duns Number:138041277

Device Description: Universal Hook Plt, 5-Hole, Template

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More Product Details

Catalog Number

UHP-5 T

Brand Name

Tools - FPS

Version/Model Number

UHP-5 T

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

HWT

Product Code Name

TEMPLATE

Device Record Status

Public Device Record Key

26459989-57fe-4b2c-895d-f13a4fa4282a

Public Version Date

February 07, 2020

Public Version Number

2

DI Record Publish Date

January 20, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TRIMED, INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 555
2 A medical device with a moderate to high risk that requires special controls. 1934