Harmony Latex Dam Bulk Box

GUDID 00860003804513

Harmony Latex Dam Bulk Box 100/box

Pamco Distributing Inc

Female condom, synthetic polymer

• Primary Device ID: 00860003804513
• NIH Device Record Key: f940bca7-1ee9-4f40-9bee-8778bb72e24f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harmony Latex Dam Bulk Box
• Version Model Number: HA-202
• Company DUNS: 208394130
• Company Name: Pamco Distributing Inc
• Device Count: 100
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003804513 [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 Bulk Box]

• 00860003804513: Harmony Latex Dam Bulk Box 100/box
• 00628347062729: Harmony Latex Dam Bulk Box 100/box