60-15486

GUDID 04546540246974

Drill, WL 8mm, Dental Shaft

Stryker Leibinger GmbH & Co. KG

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

• Primary Device ID: 04546540246974
• NIH Device Record Key: bbbddc83-08f9-4edd-9aed-c2f83fb7d6f6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 60-15486
• Catalog Number: 60-15486
• Company DUNS: 316153956
• Company Name: Stryker Leibinger GmbH & Co. KG
• 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

• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540246974 [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

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

[04546540246974]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-01
• Device Publish Date: 2016-08-24

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