Revolution 0606600000

GUDID 04546540437037

Cement Gun

STRYKER CORPORATION

Orthopaedic cement/bone filler dispensing gun

• Primary Device ID: 04546540437037
• NIH Device Record Key: 1f494b7c-57fa-462e-aff2-b21545add8ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revolution
• Version Model Number: 0606600000
• Catalog Number: 0606600000
• Company DUNS: 196548481
• Company Name: STRYKER CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540437037 [Primary]

FDA Product Code

• JDZ: MIXER, CEMENT, FOR CLINICAL USE
• KIH: DISPENSER, CEMENT

Sterilization

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

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

[04546540437037]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-09-24

On-Brand Devices [Revolution]

• 37613252722701: Full Core Biopsy Device
• 37613154354390: Cement Mixing System with Femoral Breakaway Nozzle, Medium Solid Proximal Pressurizer, Revision
• 37613154170983: MIS Breakaway Nozzle
• 37613154169697: Cement Mixing System with MIS Femoral Breakaway Nozzle and Advanced Femoral Canal Pressurizer (M
• 37613154169673: Cement Mixing System with MIS Femoral Breakaway Nozzle
• 37613154169666: Cement Mixing System with Nozzle
• 34546540912344: Cement Mixing System with Femoral Breakaway Nozzle, Medium Solid Proximal Pressurizer, Universal
• 34546540912115: Cement Mixing System with Femoral Breakway Nozzle and Medium Pressurizer
• 34546540912092: Cement Mixing System with Femoral Breakway Nozzle
• 34546540911972: Tibial Nozzle
• 34546540447914: Cement Mixing System with Femoral Breakaway Nozzle and Advanced Femoral Canal Pressurizer (Mediu
• 34546540447907: Cement Mixing System with Cancellous Nozzle and Tibial Pressurizer Tip
• 34546540447891: Cement Mixing System without Nozzle
• 34546540447877: Cancellous Nozzle with Pressurizer Kit
• 34546540447860: Syringe Tip Nozzle
• 34546540447846: Thin Flexible Nozzle
• 34546540447839: Femoral Pressurizer Nozzle
• 34546540447822: Breakaway Nozzle
• 34546540447815: Humeral Nozzle
• 04546540437037: Cement Gun