Whistler Modular Pedicle Screw System

Basic Information

• Brand Name: Whistler Modular Pedicle Screw System
• Primary DI: 00195860005347
• Version / Model: SI-013
• Catalog Number: SI-013
• Company Name: Evolution Spine LLC
• Labeler DUNS: 116940934
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-17
• Public Version: 1
• Public Version Date: 2021-05-25
• Public Version Status: New
• Public Device Record Key: a9553d66-d411-4122-8d3e-e0f557c47e94

Device Description

Compressor

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63932	Osteotomy compression/distraction instrument	A non-sterile manual surgical instrument intended to be used for compression and distraction of an osteotomy. It is comprised of two arms that attach to pins/screws/nails inserted into both sides of the cut bone, and includes a mechanism (e.g., screw) used to close and open the arms of the device enabling compression and distraction at the osteotomy line. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00195860005347	GS1

Customer Contacts

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