FDA.reportPublic FDA data

Ruthless Spine Quick Connect Axial Ratcheting Handle

Primary DI
G492RJBHND10
Brand
Ruthless Spine Quick Connect Axial Ratcheting Handle
Company
Ruthless Spine
Model
RJB-HND1
Device description
RJB System Instrument, Quick Connect Axial Ratcheting Handle
Published
2024-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QWLIntraoperative Surgical Angle Measurement Tool

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QWLIntraoperative Surgical Angle Measurement ToolOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G492RJBHND10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
855-496-3454info@ruthlessspine.com

Regulatory Flags#

DUNS number
117227055
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G492RJBFLT10Ruthless Spine Duckbill Probe, PlasticRJB-FLT1RJBFLT12025-12-09
G492RJBMPV70810Ruthless Spine MPV7 (Jamshidi Needle) Bevel Tip 8 GaugeRJB-MPV7-081RJBMPV70812025-12-09
G492RJBMPV70820Ruthless Spine MPV7 (Jamshidi Needle) Diamond Tip, 8 GaugeRJB-MPV7-082RJBMPV70822025-12-09
G492RJBMPV71010Ruthless Spine MPV7 (Jamshidi Needle) Bevel Tip, 10 GaugeRJB-MPV7-101RJBMPV71012025-12-09
G492RJBMPV71020Ruthless Spine MPV7 (Jamshidi Needle) Diamond Tip, 10 GaugeRJB-MPV7-102RJBMPV71022025-12-09
G492RJBRCT10Ruthless Spine Ratchet Handle, PlasticRJB-RCT1RJBRCT12025-12-09
G492RJBSRP10Ruthless Spine Straight Probe, PlasticRJB-SRP1RJBSRP12025-12-09
G492RJBHND1R0Ruthless Spine Quick Connect Axial Ratcheting Handle, reusableRJB-HND1-RRJBHND1R2025-01-21
G492RJBPRB1R0Ruthless Spine Straight Probe, reusableRJB-PRB1-RRJBPRB1R2025-01-21
G492RJBPRB2R0Ruthless Spine Duckbill Probe, reusableRJB-PRB2-RRJBPRB2R2025-01-21
G492RJB60Ruthless Spine RJBRJB62024-01-29
G492RJB61Ruthless Spine RJB - CaseRJB6-Case2024-01-29
G492RJBPRB10Ruthless Spine Straight ProbeRJB-PRB12024-01-29
G492RJBPRB20Ruthless Spine Duckbill ProbeRJB-PRB22024-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G492RJBFLT10Ruthless Spine Duckbill Probe, PlasticRuthless SpineQWL2025-12-09
G492RJBMPV70810Ruthless Spine MPV7 (Jamshidi Needle) Bevel Tip 8 GaugeRuthless SpineQWL2025-12-09
G492RJBMPV70820Ruthless Spine MPV7 (Jamshidi Needle) Diamond Tip, 8 GaugeRuthless SpineQWL2025-12-09
G492RJBMPV71010Ruthless Spine MPV7 (Jamshidi Needle) Bevel Tip, 10 GaugeRuthless SpineQWL2025-12-09
G492RJBMPV71020Ruthless Spine MPV7 (Jamshidi Needle) Diamond Tip, 10 GaugeRuthless SpineQWL2025-12-09
G492RJBRCT10Ruthless Spine Ratchet Handle, PlasticRuthless SpineQWL2025-12-09
G492RJBSRP10Ruthless Spine Straight Probe, PlasticRuthless SpineQWL2025-12-09
G492RJBHND1R0Ruthless Spine Quick Connect Axial Ratcheting Handle, reusableRuthless SpineQWL2025-01-21
G492RJBPRB1R0Ruthless Spine Straight Probe, reusableRuthless SpineQWL2025-01-21
G492RJBPRB2R0Ruthless Spine Duckbill Probe, reusableRuthless SpineQWL2025-01-21
G492RJB60Ruthless Spine RJBRuthless SpineQWL2024-01-29
G492RJB61Ruthless Spine RJB - CaseRuthless SpineQWL2024-01-29
G492RJBPRB10Ruthless Spine Straight ProbeRuthless SpineQWL2024-01-29
G492RJBPRB20Ruthless Spine Duckbill ProbeRuthless SpineQWL2024-01-29