Tools - DHF - Interlocking Guide, Drill Sleeve 2.3 - TRIMED, INCORPORATED

Duns Number:138041277

Device Description: Interlocking Guide, Drill Sleeve 2.3

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More Product Details

Catalog Number

SLVGDI-2.3

Brand Name

Tools - DHF

Version/Model Number

SLVGDI-2.3

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)

-

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

2acd21a3-83a8-4fec-848c-af76c363181f

Public Version Date

April 06, 2020

Public Version Number

4

DI Record Publish Date

July 28, 2017

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