91-19126

GUDID 04546540504180

Drill

Stryker Trauma SA

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

• Primary Device ID: 04546540504180
• NIH Device Record Key: 87635a38-c3fc-4a32-843c-28b9427b7049
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 91-19126
• Catalog Number: 91-19126
• 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: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0
• Length: 94 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540504180 [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

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