"2.4MM" LOCKING RECON SYSTEM 99-2693

GUDID 00841036091507

BIOMET MICROFIXATION, INC

Temporary mandibular condyle prosthesis

• Primary Device ID: 00841036091507
• NIH Device Record Key: 8c5403b8-a9a7-4fc7-af16-32067483ccac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: "2.4MM" LOCKING RECON SYSTEM
• Version Model Number: 99-2693
• Catalog Number: 99-2693
• 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: false
• 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	00841036091507 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002790

FDA Product Code

• NEI: Prosthesis, condyle, mandibular, temporary

Sterilization

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

[00841036091507]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-11

On-Brand Devices ["2.4MM" LOCKING RECON SYSTEM]

• 00841036150792: 01-2635
• 00841036091507: 99-2693
• 00841036010362: 01-2949
• 00841036009847: 01-2692
• 00841036009830: 01-2691