91-08198

GUDID 04546540506115

DRILL, WL 22MM, STRYKER-SHAFT

Stryker Leibinger GmbH & Co. KG

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

• Primary Device ID: 04546540506115
• NIH Device Record Key: 7ad6551f-ba3c-44db-a660-8a405ebf9195
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 91-08198
• Catalog Number: 91-08198
• 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: 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: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Length: 22 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540506115 [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: 2016-08-24

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