DUREX Extra Sensitive Condom

GUDID 00023409577201

Condom

RB Health (us) LLC

Basic male condom, Hevea-latex

• Primary Device ID: 00023409577201
• NIH Device Record Key: 2c582116-2789-45d2-9300-4e7e249d6ee7
• Commercial Distribution Discontinuation: 2016-12-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DUREX Extra Sensitive Condom
• Version Model Number: Condom
• Company DUNS: 081049410
• Company Name: RB Health (us) LLC
• Device Count: 1000
• 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: true
• 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: +1(800)756-5488
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat

Device Identifiers

Device Issuing Agency	Device ID
GS1	00023409577201 [Primary]
GS1	10023409577208 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980319

FDA Product Code

• HIS: CONDOM

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-18
• Device Publish Date: 2016-09-20

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• 10302340983560: Condom
• 20067981860034: Condom
• 00023409577201: Condom
• 40302340957722: Condom
• 00302340302715: Condom