OPTILOCK 22908

GUDID 00888480226796

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00888480226796
• NIH Device Record Key: 62139459-7433-488e-81e0-387536109519
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTILOCK
• Version Model Number: 22908
• Catalog Number: 22908
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• 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(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888480226796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040908

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

[00888480226796]

Moist Heat or Steam Sterilization

[00888480226796]

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: 2015-10-24

On-Brand Devices [OPTILOCK]

• 00880304532649: 22624
• 00880304520851: 00025S
• 00880304518094: 22414
• 00880304516717: 22420
• 00880304516700: 22105
• 00880304516694: 22722
• 00880304511729: 22216
• 00887868102004: 36015S
• 00888480227366: 22930
• 00888480227359: 22928
• 00888480227342: 22926
• 00888480227335: 22924
• 00888480227328: 22922
• 00888480227311: 22920
• 00888480227304: 22918
• 00888480227298: 22916
• 00888480227281: 22914
• 00888480227090: 22910
• 00888480226796: 22908
• 00888480226703: 22906
• 00888480225300: 22730
• 00888480225294: 22729
• 00888480225287: 22728
• 00888480225270: 22727
• 00888480225263: 22726
• 00888480225249: 22724
• 00888480225232: 22723
• 00888480225218: 22721
• 00888480225201: 22720
• 00888480225195: 22719
• 00888480225188: 22718
• 00888480225171: 22717
• 00888480225164: 22716
• 00888480225157: 22715
• 00888480225140: 22714
• 00888480225126: 22712
• 00888480225102: 22710
• 00888480224976: 22630
• 00888480224952: 22629
• 00888480224945: 22628
• 00888480224938: 22627
• 00888480224921: 22626
• 00888480224914: 22625
• 00888480224891: 22623
• 00888480224884: 22622
• 00888480224877: 22621
• 00888480224860: 22620
• 00888480224846: 22619
• 00888480224839: 22618
• 00888480224822: 22617