LACTOSORB® SYSTEM SP-1581

GUDID 00841036094287

BIOMET MICROFIXATION, INC

Implantable craniofacial bone distractor

• Primary Device ID: 00841036094287
• NIH Device Record Key: 45d7de08-5af4-4b70-abf8-2ebf0125d6b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LACTOSORB® SYSTEM
• Version Model Number: SP-1581
• Catalog Number: SP-1581
• 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	00841036094287 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030425

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]

• 00841036094287: SP-1581
• 00841036202163: 915-1590
• 00841036150914: 915-7430
• 00841036125653: 915-1595
• 00841036123666: 915-5002
• 00841036123079: 915-2095
• 00841036075798: SP-1316
• 00841036073862: SP-1315
• 00841036071172: 915-2175
• 00841036065027: 915-2185
• 00841036063245: 915-3350
• 00841036060466: 915-3009
• 00841036056070: 915-3012
• 00841036056063: 915-3011
• 00841036056049: 915-3008
• 00841036056025: 915-3002
• 00841036056001: 915-3000
• 00841036055837: 915-2805
• 00841036055820: 915-2804
• 00841036055738: 915-2453
• 00841036055714: 915-2451
• 00841036054342: 915-2083
• 00841036054304: 915-2075
• 00841036054151: 915-2045
• 00841036053901: 915-2002
• 00841036053819: 914-2001