Universal Neuro 2, Universal Neuro 3 91-12204

GUDID 04546540543011

DRILL, WL 4MM, DENTAL SHAFT

Stryker Leibinger GmbH & Co. KG

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

• Primary Device ID: 04546540543011
• NIH Device Record Key: 3444a3e8-0435-4c3c-b3bc-8e7547a78cff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal Neuro 2, Universal Neuro 3
• Version Model Number: 91-12204
• Catalog Number: 91-12204
• 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: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540543011 [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

On-Brand Devices [Universal Neuro 2, Universal Neuro 3]

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• 07613154481927: DRILL, WL 4MM, STRYKER SHAFT
• 07613154411603: DRILL, WL 4MM, TPS SHAFT
• 04546540684981: Drill, WL 6mm, Stryker Shaft
• 04546540684974: Drill, WL 4mm, Stryker Shaft
• 04546540684967: Drill, WL 6mm, TPS Shaft
• 04546540684950: DRILL, WL 4MM, TPS SHAFT
• 04546540543011: DRILL, WL 4MM, DENTAL SHAFT
• 04546540394156: DRILL, WL 6MM, TPS SHAFT
• 04546540366610: Drill for 18mm Screws, Dental Shaft
• 04546540366603: Drill for 8mm Screws, Dental Shaft