LACTOSORB SYSTEM - MANDIBULAR 915-3320

GUDID 00841036056131

BIOMET MICROFIXATION, INC

Implantable craniofacial bone distractor

• Primary Device ID: 00841036056131
• NIH Device Record Key: f64448d6-b9ba-423f-9994-9f06114dd10d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LACTOSORB SYSTEM - MANDIBULAR
• Version Model Number: 915-3320
• Catalog Number: 915-3320
• 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: true
• 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	00841036056131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002083

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-23
• Device Publish Date: 2015-10-11

On-Brand Devices [LACTOSORB SYSTEM - MANDIBULAR]

• 00841036159443: SP-1944
• 00841036127770: SP-1779
• 00841036126889: SP-1778
• 00841036070472: 915-3140
• 00841036063689: 915-3330
• 00841036056131: 915-3320