RTI - CLARITY DILATOR #3, 18MM - TEDAN SURGICAL INNOVATIONS, L.L.C.

Duns Number:791619393

Device Description: CLARITY DILATOR #3, 18MM

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More Product Details

Catalog Number

-

Brand Name

RTI

Version/Model Number

19-DILATOR-I8

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 16, 2020

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

2ef477b6-d02e-48c0-a295-663b3f5c40b2

Public Version Date

June 16, 2020

Public Version Number

4

DI Record Publish Date

December 25, 2017

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