SureEase Ultra 4

GUDID 00852598007271

Constriction Ring

AUGUSTA MEDICAL SYSTEMS, L.L.C.

Penile vacuum device

• Primary Device ID: 00852598007271
• NIH Device Record Key: df9a0695-dc33-436f-8ab8-d7b3b7f2c404
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureEase Ultra 4
• Version Model Number: Constriction Ring
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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	00852598007271 [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

Devices Manufactured by AUGUSTA MEDICAL SYSTEMS, L.L.C.

• 00852598007004 - Response II: 2018-03-29 Manual vacuum pump
• 00852598007011 - Soma Therapy OTC: 2018-03-29 Manual Vacuum Pump
• 00852598007028 - Elite Custom: 2018-03-29 Manual Vacuum Pump
• 00852598007035 - Somaerect Stf: 2018-03-29 Manual Vacuum Pump
• 00852598007042 - Touch II: 2018-03-29 Battery Vacuum Pump
• 00852598007059 - Soma Therapy OTC Plus: 2018-03-29 Battery Vacuum Pump
• 00852598007066 - Somaerect Stf Plus: 2018-03-29 Battery Vacuum Pump
• 00852598007073 - Elite Custom Plus: 2018-03-29 Battery Vacuum Pump