91-10115

GUDID 04546540504142

Drill

Stryker Trauma SA

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

• Primary Device ID: 04546540504142
• NIH Device Record Key: 946988fb-b325-4047-8ec0-2cd1ffc91c42
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 91-10115
• Catalog Number: 91-10115
• 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: true
• 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

• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0
• Length: 83 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540504142 [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: false
• Device Is Sterile: true

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

Devices Manufactured by Stryker Trauma SA

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• 07613327614633 - PANGEA: 2024-12-09 Tap, Locking, AO
• 07613327624786 - PANGEA: 2024-12-09 Drill Bit, MIS, AO
• 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