myONE S22 - Lubricated Male Latex Condoms - GLOBAL PROTECTION CORP.

Duns Number:364614362

Device Description: Lubricated Male Latex Condoms

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More Product Details

Catalog Number

-

Brand Name

myONE S22

Version/Model Number

MYONE-S22-12

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

HIS

Product Code Name

Condom

Device Record Status

Public Device Record Key

313d3f98-7733-4522-a7ea-08cd80d2798e

Public Version Date

June 24, 2020

Public Version Number

1

DI Record Publish Date

June 16, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GLOBAL PROTECTION CORP." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 152