SMARTFREEZE™

Basic Information

• Brand Name: SMARTFREEZE™
• Primary DI: 00191506007737
• Version / Model: M004CRBS6500
• Catalog Number: M004CRBS6500
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Labeler DUNS: 021717889
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-21
• Public Version: 1
• Public Version Date: 2023-08-29
• Public Version Status: New
• Public Device Record Key: 23c0763d-62eb-4d0f-9762-2b19138b4d44

Device Description

Remote Control

Device Characteristics

• Single Use: No
• 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: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OAE	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
65124	Cardiac cryosurgical system remote control	A hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to control the operational functions of a cardiac cryosurgical system and its components (e.g., cardiac tissue ablation catheter) from a distance via a connected cable or wirelessly, during a surgical intervention. It is intended to be operated by the healthcare provider.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00191506007737	GS1

Premarket Submissions

Submission Number	Supplement Number
P220032	000