TSI - HEX DRIVER TOOL W/ HANDLE 20MM DIAMETER - TEDAN SURGICAL INNOVATIONS, L.L.C.

Duns Number:791619393

Device Description: HEX DRIVER TOOL W/ HANDLE 20MM DIAMETER

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More Product Details

Catalog Number

-

Brand Name

TSI

Version/Model Number

MD-1468

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

GAD

Product Code Name

Retractor

Device Record Status

Public Device Record Key

5d3bce20-d00e-42c4-8c05-76bc742f9339

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 10, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TEDAN SURGICAL INNOVATIONS, L.L.C." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2398
2 A medical device with a moderate to high risk that requires special controls. 51