Imola-Silverstone

Basic Information

• Brand Name: Imola-Silverstone
• Primary DI: 00843210133744
• Version / Model: 705-3009
• Company Name: Altus Spine, LLC
• Labeler DUNS: 078331322
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-06
• Public Version: 3
• Public Version Date: 2024-07-12
• Public Version Status: Update
• Public Device Record Key: fe2a507e-ee71-434c-b7cd-4924f56f0691

Device Description

9mm Shaver, Silverstone

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
MAX	Intervertebral fusion device with bone graft, lumbar	Orthopedic	888.3080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66786	Spinal shaver system blade	A cutting device designed for use in a powered spinal decompression shaver system handpiece (not included) for bone and soft-tissue resection during spinal surgery. It is locked into the handpiece and typically consists of a small outer tube with a hub and a rotating inner tube with a connector that performs a rotational or reciprocating (back and forth) motion. It is typically made of high-grade stainless steel. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00843210133744	GS1

Customer Contacts

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