TorqMax™ 502-001

GUDID M2045020011

TorqMax™ Sheath Grip Assembly

Spectranetics Corporation

Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device

• Primary Device ID: M2045020011
• NIH Device Record Key: 2f9fb1ef-1dab-47a0-b031-81f1ff41a435
• Commercial Distribution Discontinuation: 2019-02-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: TorqMax™
• Version Model Number: 502-001
• Catalog Number: 502-001
• Company DUNS: 151047370
• Company Name: Spectranetics Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-633-0969
• Email: complaints@spnc.com
• Phone: 1-800-633-0969
• Email: complaints@spnc.com
• Phone: 1-800-633-0969
• Email: complaints@spnc.com
• Phone: 1-800-633-0969
• Email: complaints@spnc.com
• Phone: 1-800-633-0969
• Email: complaints@spnc.com
• Phone: 1-800-633-0969
• Email: complaints@spnc.com
• Phone: 1-800-633-0969
• Email: complaints@spnc.com
• Phone: 1-800-633-0969
• Email: complaints@spnc.com
• Phone: 1-800-633-0969
• Email: complaints@spnc.com
• Phone: 1-800-633-0969
• Email: complaints@spnc.com
• Phone: 1-800-633-0969
• Email: complaints@spnc.com
• Phone: 1-800-633-0969
• Email: complaints@spnc.com
• Phone: 1-800-633-0969
• Email: complaints@spnc.com
• Phone: 1-800-633-0969
• Email: complaints@spnc.com
• Phone: 1-800-633-0969
• Email: complaints@spnc.com
• Phone: 1-800-633-0969
• Email: complaints@spnc.com

Device Dimensions

• Outer Diameter: 7.5 Millimeter
• Outer Diameter: 7.5 Millimeter
• Outer Diameter: 7.5 Millimeter
• Outer Diameter: 7.5 Millimeter
• Outer Diameter: 7.5 Millimeter
• Outer Diameter: 7.5 Millimeter
• Outer Diameter: 7.5 Millimeter
• Outer Diameter: 7.5 Millimeter
• Outer Diameter: 7.5 Millimeter
• Outer Diameter: 7.5 Millimeter
• Outer Diameter: 7.5 Millimeter
• Outer Diameter: 7.5 Millimeter
• Outer Diameter: 7.5 Millimeter
• Outer Diameter: 7.5 Millimeter
• Outer Diameter: 7.5 Millimeter
• Outer Diameter: 7.5 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M2045020010 [Primary]
HIBCC	M2045020011 [Package]; Contains: M2045020010; Package: Box [2 Units]; Discontinued: 2019-02-06; Not in Commercial Distribution

FDA Product Code

• DFC: Lipoprotein, Low-Density, Antigen, Antiserum, Control

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[M2045020011]

Ethylene Oxide

[M2045020011]

Ethylene Oxide

[M2045020011]

Ethylene Oxide

[M2045020011]

Ethylene Oxide

[M2045020011]

Ethylene Oxide

[M2045020011]

Ethylene Oxide

[M2045020011]

Ethylene Oxide

[M2045020011]

Ethylene Oxide

[M2045020011]

Ethylene Oxide

[M2045020011]

Ethylene Oxide

[M2045020011]

Ethylene Oxide

[M2045020011]

Ethylene Oxide

[M2045020011]

Ethylene Oxide

[M2045020011]

Ethylene Oxide

[M2045020011]

Ethylene Oxide

[M2045020011]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-10-26
• Device Publish Date: 2014-08-19

On-Brand Devices [TorqMax™]

• M204502001AA0: TorqMax™ Sheath Grip Assembly
• M2045020011: TorqMax™ Sheath Grip Assembly