ProACT - Implantation Instrument Set

GUDID 00180668000106

UROMEDICA INC

Hydraulic male urinary incontinence treatment system

• Primary Device ID: 00180668000106
• NIH Device Record Key: b23d88e7-8d52-49c2-b9a1-e9dcc782e8be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProACT - Implantation Instrument Set
• Version Model Number: 750041
• Company DUNS: 080378479
• Company Name: UROMEDICA INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00180668000106 [Primary]

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00180668000106]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-01-23
• Device Publish Date: 2016-07-15

Devices Manufactured by UROMEDICA INC

• 00180668000144 - ProACT - Replacement Actuator - Tissue Expanding Device II: 2019-10-31
• 00180668000106 - ProACT - Implantation Instrument Set: 2019-01-23
• 00180668000106 - ProACT - Implantation Instrument Set: 2019-01-23
• 00180668000137 - ProACT - Blunt Trocar: 2019-01-23
• 00180668000205 - ProACT - Tissue Expanding Device II: 2019-01-23
• 00180668000236 - ProACT Adjustable Continence Therapy for Men – 12 cm Implants - Patient Pack: 2019-01-23
• 00180668000380 - ProACT Adjustable Continence Therapy for Men – 14 cm Implants - Patient Pack: 2019-01-23
• 00180668000397 - ProACT Adjustable Continence Therapy for Men – 12 cm Single Implant - Revision: 2019-01-23
• 00180668000403 - ProACT Adjustable Continence Therapy for Men – 14 cm Single Implant - Revision: 2019-01-23