92-15010

GUDID 07613327634976

Drill for 6514-7-200 WL 10mm

Stryker Leibinger GmbH & Co. KG

Fluted surgical drill bit, single-use

• Primary Device ID: 07613327634976
• NIH Device Record Key: b6de6c92-e6f9-4372-a583-3e122fb7a2ae
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 92-15010
• Catalog Number: 92-15010
• 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: true
• 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: 10 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Length: 21 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327634976 [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

[07613327634976]

Moist Heat or Steam Sterilization

[07613327634976]

Moist Heat or Steam Sterilization

[07613327634976]

Moist Heat or Steam Sterilization

[07613327634976]

Moist Heat or Steam Sterilization

[07613327634976]

Moist Heat or Steam Sterilization

[07613327634976]

Moist Heat or Steam Sterilization

[07613327634976]

Moist Heat or Steam Sterilization

[07613327634976]

Moist Heat or Steam Sterilization

[07613327634976]

Moist Heat or Steam Sterilization

[07613327634976]

Moist Heat or Steam Sterilization

[07613327634976]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-12-16
• Device Publish Date: 2024-07-11

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• 07613327401554 - NA: 2025-01-17 SternalPlate, T
• 07613327401561 - NA: 2025-01-17 SternalPlate, Transverse, w/ bars
• 07613327401738 - NA: 2025-01-17 SternalPlate, T