5100-015-301

GUDID 04546540494740

E-Type Bur Guard

STRYKER CORPORATION

Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic 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

Devices Manufactured by STRYKER CORPORATION

• 07613327634914 - Neptune: 2024-04-24 SMART DOCKING STATION (120V)
• 07613327627664 - KNOTILUS+: 2024-03-15 2.9X12.5MM KNOTILUS+ HIP ANCHOR - PEEK
• 07613327627701 - KNOTILUS+: 2024-03-15 2.4X8.9MM KNOTILUS+ HIP ANCHOR - PEEK
• 07613327623796 - KNOTILUS+: 2024-03-13 2.4X8.9MM DRILL, HIP
• 07613327623833 - KNOTILUS+: 2024-03-13 2.4X8.9MM DRILL, HARD BONE, HIP
• 07613327634686 - Iconix: 2024-03-12 Iconix DC Guide for 1.4mm anchor
• 07613327634693 - Iconix: 2024-03-12
• 07613327616675 - SPY: 2024-03-06