MENTOR Smooth Round SPECTRUM

Basic Information

• Brand Name: MENTOR Smooth Round SPECTRUM
• Primary DI: 00081317001997
• Version / Model: 3501450
• Catalog Number: 350-1450
• Company Name: MENTOR TEXAS L.P.
• Labeler DUNS: 167450993
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-17
• Public Version: 5
• Public Version Date: 2021-02-11
• Public Version Status: Update
• Public Device Record Key: 6109aecd-2d28-4299-8136-d34701236eef

Device Description

Post Operatively Adjustable Saline Breast Implant, 325cc |Smooth|Round|Saline|

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• 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
FWM	Prosthesis, breast, inflatable, internal, saline	General, Plastic Surgery	878.3530	3

GMDN Terms

Code	Name	Definition	Implantable	Status
64083	Saline-filled breast implant, unstructured, smooth-surface	An implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber outer shell, made of polysiloxane(s), with a single lumen inflated with sterile isotonic saline to the desired size; the shell surface is smooth. The implant may be of fixed or adjustable volume and may be prefilled, partially filled, or empty and filled during the implantation procedure; the volume of saline solution in adjustable volume implants may be adjusted after implantation. The device may vary in shape, profile, volume and shell thickness.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00081317001997	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P990075	019