Harmony Latex Dam Retail Pack

GUDID 00860003804537

Harmony Latex Dam Retail Pack 6/pack

Pamco Distributing Inc

Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer

• Primary Device ID: 00860003804537
• NIH Device Record Key: bbdaa0ae-d1c7-47dd-973e-2bef5f68e250
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harmony Latex Dam Retail Pack
• Version Model Number: HA-202-R
• Company DUNS: 208394130
• Company Name: Pamco Distributing Inc
• Device Count: 6
• 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: true
• 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	00860003804537 [Primary]
GS1	00860003804551 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203727

FDA Product Code

• MSC: Barrier, Std, Oral Sex

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: 2022-02-25
• Device Publish Date: 2022-02-17

On-Brand Devices [Harmony Latex Dam Retail Pack]

• 00860003804537: Harmony Latex Dam Retail Pack 6/pack
• 00628347069810: Harmony Latex Dam Retail Pack 6/pack