92-16115

GUDID 07613327634945

Drill for 4/5mm screws SYK

Stryker Leibinger GmbH & Co. KG

Fluted surgical drill bit, single-use

• Primary Device ID: 07613327634945
• NIH Device Record Key: 1552190e-94fc-4c2e-958d-a08cc05549fc
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 92-16115
• Catalog Number: 92-16115
• 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: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Length: 115 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327634945 [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

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

[07613327634945]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-01
• Device Publish Date: 2024-09-23

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

• 07613327401523 - NA: 2025-01-17 SternalPlate, Transverse, w/ bars
• 07613327401554 - NA: 2025-01-17 SternalPlate, T
• 07613327401561 - NA: 2025-01-17 SternalPlate, Transverse, w/ bars
• 07613327401738 - NA: 2025-01-17 SternalPlate, T
• 07613327634952 - NA: 2024-12-16 Drill for 6514-7-200 WL 16mm
• 07613327634969 - NA: 2024-12-16 Drill for 6514-7-200 WL 12mm
• 07613327634976 - NA: 2024-12-16 Drill for 6514-7-200 WL 10mm
• 07613327634983 - NA: 2024-12-16 Drill for 6514-7-200 WL 12mm