XO! QA-224

GUDID 09556807342306

Natural latex male condom. Transparent, cylindrical shaped, nominal width 53 mm, smooth with reservoir. Lubricated with silicone oil. 100% electronically tested.”

RICHTER RUBBER TECHNOLOGY SDN. BHD.

Basic male condom, Hevea-latex

• Primary Device ID: 09556807342306
• NIH Device Record Key: 1a4708b6-5356-47e1-9bb3-29f2e149bc37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XO!
• Version Model Number: Ultra Thin 12's
• Catalog Number: QA-224
• Company DUNS: 652647942
• Company Name: RICHTER RUBBER TECHNOLOGY SDN. BHD.
• Device Count: 12
• DM Exempt: true
• 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: true
• 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

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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	09556807342306 [Unit of Use]
GS1	29556807382283 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070511

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: 2025-03-07
• Device Publish Date: 2025-02-27

On-Brand Devices [XO!]

• 09556807402499: Natural latex male condom. Transparent, cylindrical shaped, nominal width 53 mm, smooth with res
• 09556807403304: Natural latex male condom. Transparent, cylindrical shaped, nominal width 53 mm, smooth with res
• 09556807342337: Natural latex male condom. Transparent, anatomical shaped, nominal width 56 mm, textured with re
• 09556807342306: Natural latex male condom. Transparent, cylindrical shaped, nominal width 53 mm, smooth with res
• 09556807322278: Natural latex male condom. Transparent, anatomical shaped, nominal width 56 mm, textured with re
• 09556807322247: Natural latex male condom. Transparent, cylindrical shaped, nominal width 53 mm, smooth with res
• 09556807501949: Natural latex male condom. Transparent, anatomically shaped, nominal width 56 mm, smooth with re