NA

Basic Information

• Brand Name: NA
• Primary DI: 00802526480546
• Version / Model: 6628
• Catalog Number: 6628
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Labeler DUNS: 106295384
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-24
• Public Version: 4
• Public Version Date: 2023-02-28
• Public Version Status: Update
• Public Device Record Key: 4d68c900-1a80-4aaf-a113-593e50e31140

Device Description

BIDIRECTIONAL TORQUE WRENCH No2

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
LWP	Implantable pulse generator, pacemaker (non-CRT)	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
63133	Surgical torque wrench, single-use	A sterile hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00802526480546	GS1

Premarket Submissions

Submission Number	Supplement Number
P010012	203
P010012	295
P010012	458
P010012	558