MULTI-GUIDE 62-01010

GUDID 04546540257680

MANDIBULAR DISTRACTION DEVICE

Stryker Leibinger GmbH & Co. KG

Implantable craniofacial bone distractor

• Primary Device ID: 04546540257680
• NIH Device Record Key: 02b66b13-9fff-4029-b8d7-1a338a9e3daf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MULTI-GUIDE
• Version Model Number: 62-01010
• Catalog Number: 62-01010
• 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: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540257680 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960297

FDA Product Code

• MQN: EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04546540257680]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-23
• Device Publish Date: 2015-09-24

On-Brand Devices [MULTI-GUIDE]

• 04546540257796: TROCAR F. DRILL GUIDE
• 04546540257789: CHEEK RETRACTOR F. DRILL GUIDE
• 04546540257772: SINGLE DRILL GUIDE INSERT
• 04546540257765: DOUBLE DRILL GUIDE INSERT
• 04546540257758: HANDLE FOR DRILL GUIDE
• 04546540257734: TRANSVERSE ACTIVATION TOOL
• 04546540257727: ANGULAR ACTIVATION TOOL
• 04546540257710: LINEAR ACTIVATION TOOL, COMBINATION
• 04546540257697: PIN CLAMP, RIGHT
• 04546540257680: MANDIBULAR DISTRACTION DEVICE
• 04546540257673: MANDIBULAR DISTRACTION DEVICE
• 04546540246905: DRILL, WL 20MM, DENTAL-SHAFT
• 04546540210289: STORAGE CONTAINER
• 04546540133946: BLADE FOR THREAD. PINS AND CLAMP. SCREWS
• 34546540259074: SELF-DRILLING PINS, AUTO PILOT
• 34546540259067: SELF-DRILLING PINS, AUTO PILOT
• 34546540259050: SELF-DRILLING PINS, AUTO PILOT