Model 4625 ACUITY® X4 Connector Tool

Basic Information

• Brand Name: Model 4625 ACUITY® X4 Connector Tool
• Primary DI: 00802526527456
• Version / Model: 4625
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Labeler DUNS: 106295384
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-02-09
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: b2a6f941-3a21-442d-8329-ea00f58f2351

Device Description

Connector Tool

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: No
• 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
NVY	Permanent defibrillator electrodes	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
33500	Pacing/defibrillation lead repair kit	A collection of sterile tools and materials designed to repair the lead of an implantable pacemaker or an implantable cardioverter-defibrillator (ICD). Typical components include a screwdriver, wrench, screws, crimps, adhesives, sealants, and other items used to repair a pacemaker lead or to reconnect a pacemaker/defibrillator lead to a pacemaker/defibrillator generator. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00802526527456	GS1

Premarket Submissions

Submission Number	Supplement Number
P910073	128