Sustain Natural 10XL04

GUDID 00856078005382

Lubricated Natural Latex Condom XL w/ ribs & dots

Sustain

Basic male condom, Hevea-latex

• Primary Device ID: 00856078005382
• NIH Device Record Key: b1d82698-fc79-465d-a9c8-cf719165fa84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sustain Natural
• Version Model Number: Sustain XL condoms w/ ribs & dots (10 pack)
• Catalog Number: 10XL04
• Company DUNS: 079496130
• Company Name: Sustain
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 8028462849
• Email: questions@sustainnatural.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856078005382 [Primary]
GS1	00856078005870 [Unit of Use]
GS1	10856078005389 [Package]; Package: Inner Carton [6 Units]; In Commercial Distribution
GS1	20856078005386 [Package]; Contains: 10856078005389; Package: master case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131866

FDA Product Code

• HIS: Condom

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-09
• Device Publish Date: 2018-06-06

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• 00856078005382: Lubricated Natural Latex Condom XL w/ ribs & dots