ProACT - Replacement Actuator - Tissue Expanding Device II

Basic Information

• Brand Name: ProACT - Replacement Actuator - Tissue Expanding Device II
• Primary DI: 00180668000144
• Version / Model: 750043
• Company Name: UROMEDICA INC
• Labeler DUNS: 080378479
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-15
• Public Version: 4
• Public Version Date: 2019-10-31
• Public Version Status: Update
• Public Device Record Key: ebc91e8e-ef69-4985-b05d-e72a14259128
• Distribution End Date: 2016-07-15

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

GMDN Terms

Code	Name	Definition	Implantable	Status
31994	Hydraulic male urinary incontinence treatment system	An assembly of implantable devices intended to treat male urinary incontinence by applying pressure to partially/fully occlude the bladder neck and/or urethra, typically after radical prostatectomy or transurethral resection of the prostate. It typically consists of an inflatable pad-like device(s) (e.g., cushion, balloon) implanted around the bladder neck/urethra, port and tubing for the introduction/removal of fluid (e.g. saline) to/from the pad(s) intra- and/or postoperatively, and devices for the stabilization of the pad(s) in situ (e.g., sutures, mesh); devices for the introduction/removal of fluid via the port (e.g., needles) may also be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00180668000144	GS1