EDP EDP-MOS100

GUDID 00850004857113

Manual Penile Rigidity Device.

REACH MEDICAL, INC.

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• Primary Device ID: 00850004857113
• NIH Device Record Key: 0b093d71-e957-4f6f-862d-44f4f4988e50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDP
• Version Model Number: EDP-MOS100
• Catalog Number: EDP-MOS100
• Company DUNS: 127526064
• Company Name: REACH MEDICAL, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850004857113 [Primary]

FDA Product Code

• LKY: Device, External Penile Rigidity

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: 2024-01-26
• Device Publish Date: 2024-01-18

On-Brand Devices [EDP ]

• 00850004857069: External Penile Rigidity Device Manual and Battery Operated
• 00850004857052: External Penile Rigidity Device Battery Operated
• 00850004857045: External Penile Rigidity Device Manually Operated
• 00850004857113: Manual Penile Rigidity Device.