TACTRA

Basic Information

• Brand Name: TACTRA
• Primary DI: 08714729979357
• Version / Model: 720081-01
• Catalog Number: 720081-01
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Labeler DUNS: 021717889
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-06
• Public Version: 1
• Public Version Date: 2019-05-14
• Public Version Status: New
• Public Device Record Key: 912d8082-98af-46ad-be3b-3bd208d68434

Device Description

Malleable Penile Prosthesis

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FAE	PROSTHESIS, PENILE	Gastroenterology, Urology	876.3630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36251	Rigid penile prosthesis	A rigid or semi-rigid sterile rod or cylinder-like device intended to be surgically implanted in the corpora cavernosa of the penis in a patient with erectile dysfunction (ED) [commonly known as impotence] in order to achieve permanent penile tumescence and rigidity adequate for vaginal intercourse. This device is available in a variety of designs and materials such as: 1) a flexible solid rod of polymer; 2) a flexible polymer or silicone cylinder with an internal silver (Ag) coil core; or 3) a single- or multiple-hinged rod enabling the user to position the penis downwards for better concealment under clothing.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08714729979357	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			11mm