Shaped Breast Implant Sizer, Oval Base, Moderate Projection

Basic Information

• Brand Name: Shaped Breast Implant Sizer, Oval Base, Moderate Projection
• Primary DI: M746SZ20645500MP0
• Version / Model: SZ20645-500MP
• Catalog Number: SZ20645=500MP
• Company Name: SPECIALTY SURGICAL PRODUCTS INC
• Labeler DUNS: 002112626
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-01
• Public Version: 3
• Public Version Date: 2020-12-21
• Public Version Status: Update
• Public Device Record Key: 8af4dcd1-a78c-4d8b-93e7-f5ddeaf54e5b

Device Description

Single Use Sterile Saline Breast Implant Sizer, Shaped, Oval Base, Moderate Projection, Footprint Based on Sientra Style 20645MP Implant, 500cc

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
MRD	Sizer, Mammary, Breast Implant Volume	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
34178	Invasive breast implant sizer, fixed, single-use	A device intended to be placed intraoperatively in a surgically-prepared mammary pocket to provide a volume measurement for the appropriate selection of a breast implant (mammary prosthesis). The device consists of a balloon-like elastomer shell that is either filled to an optimal volume via tubing and port, or is prefilled with a fixed amount of silicone gel, which is placed in the pocket and then removed. The sizer may vary in shape, profile, and volume. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M746SZ20645500MP0	HIBCC

Customer Contacts

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