EDP MAXRC EDP-MAXRC

GUDID 00850004857106

Rechargeable Penile Rigidity Device.

REACH MEDICAL, INC.

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• Primary Device ID: 00850004857106
• NIH Device Record Key: 87d8ae8c-e2d3-48e4-b2fd-d3d0de8cc695
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDP MAXRC
• Version Model Number: EDP-MAXRC
• Catalog Number: EDP-MAXRC
• 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	00850004857106 [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: 2024-01-05
• Device Publish Date: 2023-12-28

Devices Manufactured by REACH MEDICAL, INC.

• 00850004857113 - EDP: 2024-01-26 Manual Penile Rigidity Device.
• 00850004857106 - EDP MAXRC: 2024-01-05Rechargeable Penile Rigidity Device.
• 00850004857106 - EDP MAXRC: 2024-01-05 Rechargeable Penile Rigidity Device.
• 00850004857045 - EDP: 2020-01-08 External Penile Rigidity Device Manually Operated
• 00850004857052 - EDP: 2020-01-08 External Penile Rigidity Device Battery Operated
• 00850004857069 - EDP: 2020-01-08 External Penile Rigidity Device Manual and Battery Operated
• 00850004857007 - Penile Adjustable Loop: 2019-03-08 Adjustable penile constriction band that can be used with or without a vacuum erection device.