XO! QA-224

GUDID 09556807322247

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: 09556807322247
• NIH Device Record Key: 9aadc07d-9d99-4666-9833-ba5c6b31c707
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XO!
• Version Model Number: Ultra thin 6's
• Catalog Number: QA-224
• Company DUNS: 652647942
• Company Name: RICHTER RUBBER TECHNOLOGY SDN. BHD.
• Device Count: 6
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09556807322247 [Unit of Use]
GS1	29556807352224 [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

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• 09556807322247: Natural latex male condom. Transparent, cylindrical shaped, nominal width 53 mm, smooth with res
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