BLUE DEVICE SP-1318

GUDID 00841036075309

BIOMET MICROFIXATION, INC

Implantable craniofacial bone distractor

• Primary Device ID: 00841036075309
• NIH Device Record Key: 9e0453cf-7ef1-4d46-97d8-267badcff383
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BLUE DEVICE
• Version Model Number: SP-1318
• Catalog Number: SP-1318
• Company DUNS: 046189866
• Company Name: BIOMET MICROFIXATION, INC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036075309 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020407

FDA Product Code

• MQN: EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Sterilization

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

[00841036075309]

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: 2015-10-01

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