SAVI®

Basic Information

• Brand Name: SAVI®
• Primary DI: 00884450433904
• Version / Model: 00884450433904
• Catalog Number: SPC-01/B
• Company Name: MERIT MEDICAL SYSTEMS, INC.
• Labeler DUNS: 117056277
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-06
• Public Version: 3
• Public Version Date: 2021-10-11
• Public Version Status: Update
• Public Device Record Key: 8da4db64-6358-4b8b-9068-897a5dee43d0

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
JAQ	System, applicator, radionuclide, remote-controlled	Radiology	892.5700	2

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	00884450433904	GS1