Trustex - Trustex Extra Large Latex Condom - LUNAMAX LLC

Duns Number:106855461

Device Description: Trustex Extra Large Latex Condom

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More Product Details

Catalog Number

-

Brand Name

Trustex

Version/Model Number

GS164

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)

Yes

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

K113061

Product Code Details

Product Code

HIS

Product Code Name

Condom

Device Record Status

Public Device Record Key

914750ff-cfa4-4bd7-8f2e-b5e05ae32676

Public Version Date

February 18, 2019

Public Version Number

1

DI Record Publish Date

January 16, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LUNAMAX LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 78