Torque Device
RADIFOCUS - XX*RF02AH
Device Description
A sterile hand-operated device intended to be attached to the proximal end of an invasive device (e.g., a catheter, a needle, or a guidewire) to provide the operator with the ability to manually manipulate and control the directional torque (rotation) of the device to which it is attached. This device may be made of plastic or metal materials. This is a single-use device.
Environmental Conditions
- AVOID EXPOSURE TO WATER, DIRECT SUNLIGHT, HIGH TEMPERATURES, OR HIGH HUMIDITY,DURING STORAGE,Stacking limit by 5,FRAGILE,HANDLE WITH CARE,KEEP AWAY FROM RAIN,KEEP AWAY FROM SUNLIGHT.
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: MOF
Device Name: Guide, Wire, Catheter, Neurovasculature
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: NE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.1330
Third Party Flag: Y
Medical Specialty: CV
Code: PTL
Device Name: Wire, Guide, Catheter, Exempt
Device Class: 2
Physical State: Exemption is limited to accessory torque devices that are manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guidewires.
Definition: This product code is the class II exempt counterpart of DQX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Submission Type ID: 4
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: This product code is the class II exempt counterpart of DQX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: This product code is the class II exempt counterpart of DQX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Regulation Number: 870.1330
Third Party Flag: N
Medical Specialty: CV
Device IdentifiersDevice Id: 56927675513484
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 36927675513480
Package Quantity: 4
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Large Unit box
Device Id: 36927675513480
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 76927675513488
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 56927675513484
Package Quantity: 20
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Shipping carton
Device Id: 06927675513489
Device Type: Unit of Use
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A