Elite Custom

GUDID 00852598007134

Manual Operated device that contains kit bag, manual vacuum pump, constriction rings, cylinder, lubricant, comfort inserts, loading cone.

AUGUSTA MEDICAL SYSTEMS, L.L.C.

Penile vacuum device

• Primary Device ID: 00852598007134
• NIH Device Record Key: c32972c9-d933-4a51-961f-aae7cb952b67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elite Custom
• Version Model Number: External Penile Rigidity Device
• Company DUNS: 052255606
• Company Name: AUGUSTA MEDICAL SYSTEMS, L.L.C.
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 800-827-8382
• Email: somatherapy@augustams.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852598007134 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-07-17

On-Brand Devices [Elite Custom]

• 00852598007134: Manual Operated device that contains kit bag, manual vacuum pump, constriction rings, cylinder,
• 00852598007028: Manual Vacuum Pump