Somaerect Stf

GUDID 00852598007165

External Penile Rigidity Device that contains kit bag, manual vacuum pump, constriction rings, cylinder, insert cylinders, cylinder inserts, loading cone, lubricant and standard cylinder

AUGUSTA MEDICAL SYSTEMS, L.L.C.

Penile vacuum device

• Primary Device ID: 00852598007165
• NIH Device Record Key: 1e123b61-6f17-423a-9c6e-5902fe8d1f89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Somaerect Stf
• 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	00852598007165 [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 [Somaerect Stf]

• 00852598007165: External Penile Rigidity Device that contains kit bag, manual vacuum pump, constriction rings, c
• 00852598007035: Manual Vacuum Pump