Caliber

GUDID 00860011454892

Latex male condom for contraception and prevention of sexually transmitted infections. Lubricated, sterile, single-use, over-the-counter device.

Caliber Brand LLC

Basic male condom, Hevea-latex

• Primary Device ID: 00860011454892
• NIH Device Record Key: eb0804d7-f035-44af-9adb-a29776f19225
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Caliber
• Version Model Number: 311292518
• Company DUNS: 061265830
• Company Name: Caliber Brand LLC
• Device Count: 12
• 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: 6193632647
• Email: info@caliberbrand.com
• Phone: 6193632647
• Email: info@caliberbrand.com
• Phone: 6193632647
• Email: info@caliberbrand.com
• Phone: 6193632647
• Email: info@caliberbrand.com
• Phone: 6193632647
• Email: info@caliberbrand.com
• Phone: 6193632647
• Email: info@caliberbrand.com
• Phone: 6193632647
• Email: info@caliberbrand.com
• Phone: 6193632647
• Email: info@caliberbrand.com
• Phone: 6193632647
• Email: info@caliberbrand.com
• Phone: 6193632647
• Email: info@caliberbrand.com
• Phone: 6193632647
• Email: info@caliberbrand.com
• Phone: 6193632647
• Email: info@caliberbrand.com
• Phone: 6193632647
• Email: info@caliberbrand.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011454816 [Primary]
GS1	00860011454892 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210208

FDA Product Code

• HIS: Condom

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-03
• Device Publish Date: 2025-03-26

On-Brand Devices [Caliber]

• 00860011454861: Latex male condom for contraception and prevention of sexually transmitted infections. Lubricate
• 00860013783532: Latex male condom for contraception and prevention of sexually transmitted infections. Lubricate
• 00860013783525: Latex male condom for contraception and prevention of sexually transmitted infections. Lubricate
• 00860013783518: Latex male condom for contraception and prevention of sexually transmitted infections. Lubricate
• 00860013783501: Latex male condom for contraception and prevention of sexually transmitted infections. Lubricate
• 00860011454892: Latex male condom for contraception and prevention of sexually transmitted infections. Lubricate
• 00860011454885: Latex male condom for contraception and prevention of sexually transmitted infections. Lubricate