Ruthless Spine MPV7 (Jamshidi Needle) Diamond Tip, 8 Gauge

Basic Information

• Brand Name: Ruthless Spine MPV7 (Jamshidi Needle) Diamond Tip, 8 Gauge
• Primary DI: G492RJBMPV70820
• Version / Model: RJB-MPV7-082
• Catalog Number: RJBMPV7082
• Company Name: Ruthless Spine
• Labeler DUNS: 117227055
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-09
• Public Version: 1
• Public Version Date: 2025-12-17
• Public Version Status: New
• Public Device Record Key: 3837aa9e-f00e-4b3b-aeb2-37a72a8d3c7b

Device Description

Ruthless Spine System (Jamshidi Needle) MPV7 Diamon Tip, 8 Gauge

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: Yes
• 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
QWL	Intraoperative Surgical Angle Measurement Tool	Orthopedic	888.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35212	Spinal needle, single-use	A sharp bevel-edged, hollow tubular instrument designed for short-term use to withdraw a sample of cerebrospinal fluid (CSF), assist introduction of a spinal guidewire or catheter (e.g., lumboperitoneal shunt, intrathecal catheter), and/or deliver contrast media and/or anaesthetic or analgesic agents intrathecally (subarachnoid) or into a vertebral disc, either directly or using the needle-through-needle technique. It is typically fenestrated, spring-tipped, and made of metal and/or plastic materials; some types may be semi-rigid and include a stylet for support during handling. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G492RJBMPV70820	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K252615	000