Sustain 10TF01

GUDID 00856078005016

Lubricated Natural Latex Condom

Sustain

Basic male condom, Hevea-latex

• Primary Device ID: 00856078005016
• NIH Device Record Key: d8d37fbb-e7fd-4462-ae54-7374e862ec4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sustain
• Version Model Number: Sustain Natural Tailored fit condoms (10 pack)
• Catalog Number: 10TF01
• 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	00856078005016 [Primary]
GS1	00856078005825 [Unit of Use]
GS1	10856078005013 [Package]; Package: Inner Carton [6 Units]; In Commercial Distribution
GS1	20856078005010 [Package]; Contains: 10856078005013; 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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-24

On-Brand Devices [Sustain]

• 20856078005393: Lubricated Natural Latex Condom
• 00856078005184: Unscented Personal Lubricant made with 96% Organic ingredients.
• 20856078005171: Sustain Lavender Personal lubricant, made with 95% Organic Ingredients.
• 20856078005058: Lubricated Natural Latex Condom
• 00856078005047: Lubricated Natural Latex condom
• 20856078005034: Lubricated Natural Latex Condom
• 20856078005027: Lubricated Natural Latex Condom
• 00856078005016: Lubricated Natural Latex Condom