ASTRA Spine System

Basic Information

• Brand Name: ASTRA Spine System
• Primary DI: 00193082154355
• Version / Model: 6300-71-65N
• Catalog Number: 6300-71-65N
• Company Name: SPINECRAFT, LLC
• Labeler DUNS: 783908713
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-11
• Public Version: 2
• Public Version Date: 2023-12-11
• Public Version Status: Update
• Public Device Record Key: 4c8632f1-3204-4e01-9b7f-9714d3d0279b

Device Description

ASTRA Cannulated Dia. 6.50mm Tap - Navigated

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
OLO	Orthopedic stereotaxic instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45169	Stereotactic surgery system probe, reusable	A slender, rod-like, hand-held manual surgical instrument intended for use during image-guided surgery (e.g., neurosurgical or orthopaedic surgery procedures) to accurately position implantable devices (e.g., shunts), or to correlate the position of its tip with that of a targeted tissue of interest in a patient so the tissue area is precisely identified with respect to diagnostic images stored in the stereotactic surgery system. It is made of metal. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00193082154355	GS1

Customer Contacts

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