Tools-SHD - Small Headed Screw Tray - TRIMED, INCORPORATED

Duns Number:138041277

Device Description: Small Headed Screw Tray

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More Product Details

Catalog Number

SHD-TRAY

Brand Name

Tools-SHD

Version/Model Number

SHD-TRAY

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

-

Prescription Use (Rx)

Yes

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

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Record Status

Public Device Record Key

b7c76821-cc76-431b-bbda-0310f46139a8

Public Version Date

September 16, 2022

Public Version Number

3

DI Record Publish Date

April 07, 2021

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