Spectra RTE Kit

Basic Information

• Brand Name: Spectra RTE Kit
• Primary DI: 00878953005393
• Version / Model: 720170-01
• Company Name: AMERICAN MEDICAL SYSTEMS, INC.
• Labeler DUNS: 125111448
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-12
• Public Version: 4
• Public Version Date: 2019-02-13
• Public Version Status: Update
• Public Device Record Key: 8ec2f502-7a2e-472f-80ab-9d1e26e31bd5

Device Description

Rear Tip Extender Kit 2 Each: 0.5 cm, 1.0 cm, 1.5 cm, 2.0 cm, 3.0 cm

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: Yes
• 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
60781	Penile prosthesis extender	A sterile implantable device intended to extend the cylinder component of a penile prosthesis to achieve an overall cylinder length which fits the measurements of the patient's anatomy (i.e., corpora cavernosa length). It is a synthetic polymer (e.g., silicone) moulded cap available in a variety of sizes and is intended to be attached to the end of a penile prosthesis cylinder during implantation, in cases where the cylinder is of insufficient length.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00878953005393	GS1

Device Sizes

Type	Value	Unit	Text
Outer Diameter	9.5	Millimeter
Length	3.0	Centimeter
Length	2.0	Centimeter
Length	1.5	Centimeter
Length	1.0	Centimeter
Length	0.5	Centimeter