5100-015-301

GUDID 04546540494740

E-Type Bur Guard

STRYKER CORPORATION

Drilling power tool attachment, basic

• Primary Device ID: 04546540494740
• NIH Device Record Key: f6bab50a-21f9-4cec-9bea-851b11057962
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5100015301
• Catalog Number: 5100-015-301
• Company DUNS: 196548481
• Company Name: STRYKER 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540494740 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032117

FDA Product Code

• EIA: UNIT, OPERATIVE DENTAL

Sterilization

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

[04546540494740]

Moist Heat or Steam Sterilization

[04546540494740]

Moist Heat or Steam Sterilization

[04546540494740]

Moist Heat or Steam Sterilization

[04546540494740]

Moist Heat or Steam Sterilization

[04546540494740]

Moist Heat or Steam Sterilization

[04546540494740]

Moist Heat or Steam Sterilization

[04546540494740]

Moist Heat or Steam Sterilization

[04546540494740]

Moist Heat or Steam Sterilization

[04546540494740]

Moist Heat or Steam Sterilization

[04546540494740]

Moist Heat or Steam Sterilization

[04546540494740]

Moist Heat or Steam Sterilization

[04546540494740]

Moist Heat or Steam Sterilization

[04546540494740]

Moist Heat or Steam Sterilization

[04546540494740]

Moist Heat or Steam Sterilization

[04546540494740]

Moist Heat or Steam Sterilization

[04546540494740]

Moist Heat or Steam Sterilization

[04546540494740]

Moist Heat or Steam Sterilization

[04546540494740]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-20
• Device Publish Date: 2018-09-24

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• 07613327648515 - Surpass Elite: 2025-03-17 Flow Diverter System
• 07613327648522 - Surpass Elite: 2025-03-17 Flow Diverter System