60-15496

GUDID 04546540246981

Drill, WL 16mm, Dental Shaft

Stryker Leibinger GmbH & Co. KG

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

• Primary Device ID: 04546540246981
• NIH Device Record Key: a220cecb-b6c2-4535-b759-f88004aa4e68
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 60-15496
• Catalog Number: 60-15496
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Length: 29 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540246981 [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

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

Moist Heat or Steam Sterilization

[04546540246981]

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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• 07613327634983 - NA: 2024-12-16 Drill for 6514-7-200 WL 12mm
• 07613327634990 - NA: 2024-12-16 Drill for 6514-7-200 14mm
• 07613327635003 - NA: 2024-12-16 Drill for 6514-7-200 WL 10mm
• 07613327635010 - NA: 2024-12-16 Drill for 6514-7-200 WL 14mm
• 07613327651058 - NA: 2024-11-20 T-plate malleable left