AMS 700™ with TENACIO™ Pump Accessory Kit

Basic Information

• Brand Name: AMS 700™ with TENACIO™ Pump Accessory Kit
• Primary DI: 00191506021696
• Version / Model: 72404850
• Catalog Number: 72404850
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Labeler DUNS: 021717889
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-26
• Public Version: 1
• Public Version Date: 2024-02-05
• Public Version Status: New
• Public Device Record Key: dd8d1d3d-f1cb-4753-8751-14317903ec0f

Device Description

Inflatable Penile Prosthesis Accessory Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
JCW	Prosthesis, penis, inflatable	Gastroenterology, Urology	876.3350	3

GMDN Terms

Code	Name	Definition	Implantable	Status
60787	Penile prosthesis implantation kit	A collection of manual surgical instruments intended to be used during implantation of a penile prosthesis [for the treatment of erectile dysfunction (ED)]. The kit typically contains tools associated with insertion, measurement, and/or assembly of the implant; it does not contain any pharmaceuticals. This is a reusable device intended to be sterilized prior to use; it may contain disposable items that need to be replenished before reuse.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00191506021696	GS1

Premarket Submissions

Submission Number	Supplement Number
N970012	197