92-60170

GUDID 07613154583911

TWIST DRILL, TWIST LENGTH 22MM, AO SHAFT

Stryker Trauma SA

Fluted surgical drill bit, single-use, non-sterile

• Primary Device ID: 07613154583911
• NIH Device Record Key: abe48d6c-3af5-43cb-a635-419a39f061f1
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 92-60170
• Catalog Number: 92-60170
• Company DUNS: 481999654
• Company Name: Stryker Trauma SA
• 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: true
• Lot Batch: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Length: 66 Millimeter
• Device Size Text, specify: 0
• Length: 66 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613154583911 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070876

FDA Product Code

• HBE: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Sterilization

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

[07613154583911]

Moist Heat or Steam Sterilization

[07613154583911]

Moist Heat or Steam Sterilization

[07613154583911]

Moist Heat or Steam Sterilization

[07613154583911]

Moist Heat or Steam Sterilization

[07613154583911]

Moist Heat or Steam Sterilization

[07613154583911]

Moist Heat or Steam Sterilization

[07613154583911]

Moist Heat or Steam Sterilization

[07613154583911]

Moist Heat or Steam Sterilization

[07613154583911]

Moist Heat or Steam Sterilization

[07613154583911]

Moist Heat or Steam Sterilization

[07613154583911]

Moist Heat or Steam Sterilization

[07613154583911]

Moist Heat or Steam Sterilization

[07613154583911]

Moist Heat or Steam Sterilization

[07613154583911]

Moist Heat or Steam Sterilization

[07613154583911]

Moist Heat or Steam Sterilization

[07613154583911]

Moist Heat or Steam Sterilization

[07613154583911]

Moist Heat or Steam Sterilization

[07613154583911]

Moist Heat or Steam Sterilization

[07613154583911]

Moist Heat or Steam Sterilization

[07613154583911]

Moist Heat or Steam Sterilization

[07613154583911]

Moist Heat or Steam Sterilization

[07613154583911]

Moist Heat or Steam Sterilization

[07613154583911]

Moist Heat or Steam Sterilization

[07613154583911]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-09-24

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• 07613327624809 - PANGEA: 2024-12-09 Tissue Protection Sleeve, MIS
• 07613327624816 - PANGEA: 2024-12-09 Variable Angle Drill Guide, MIS
• 07613327624830 - PANGEA: 2024-12-09 Aiming Block Distal Lateral Femur MIS, L
• 07613327624847 - PANGEA: 2024-12-09 Plate Hole Marker, MIS
• 07613327624861 - PANGEA: 2024-12-09 Plate Hole Marker, MIS
• 07613327624878 - PANGEA: 2024-12-09 Drill Sleeve Insert, MIS