AIM™DYNAMIC TIBIAL NAIL 810511300

GUDID 00887868035111

Biomet Orthopedics, LLC

Tibia nail, non-sterile

• Primary Device ID: 00887868035111
• NIH Device Record Key: 47d125ef-709e-45df-84b6-ff31ea24a602
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIM™DYNAMIC TIBIAL NAIL
• Version Model Number: 8105-11-300
• Catalog Number: 810511300
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868035111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972183

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

[00887868035111]

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 [AIM™DYNAMIC TIBIAL NAIL]

• 00887868035418: 8105-13-420
• 00887868035401: 8105-13-405
• 00887868035395: 8105-13-390
• 00887868035388: 8105-13-375
• 00887868035371: 8105-13-360
• 00887868035364: 8105-13-345
• 00887868035357: 8105-13-330
• 00887868035340: 8105-13-315
• 00887868035333: 8105-13-300
• 00887868035326: 8105-13-285
• 00887868035319: 8105-13-255
• 00887868035302: 8105-12-420
• 00887868035296: 8105-12-405
• 00887868035289: 8105-12-390
• 00887868035272: 8105-12-375
• 00887868035265: 8105-12-360
• 00887868035258: 8105-12-345
• 00887868035241: 8105-12-330
• 00887868035234: 8105-12-315
• 00887868035227: 8105-12-300
• 00887868035210: 8105-12-285
• 00887868035203: 8105-12-270
• 00887868035197: 8105-11-420
• 00887868035180: 8105-11-405
• 00887868035173: 8105-11-390
• 00887868035166: 8105-11-375
• 00887868035159: 8105-11-360
• 00887868035142: 8105-11-345
• 00887868035135: 8105-11-330
• 00887868035128: 8105-11-315
• 00887868035111: 8105-11-300
• 00887868035104: 8105-11-285
• 00887868035098: 8105-11-270
• 00887868035081: 8105-11-255
• 00887868035074: 8105-10-420
• 00887868035067: 8105-10-405
• 00887868035050: 8105-10-390
• 00887868035043: 8105-10-375
• 00887868035036: 8105-10-360
• 00887868035029: 8105-10-345
• 00887868035012: 8105-10-330
• 00887868035005: 8105-10-315
• 00887868034992: 8105-10-300
• 00887868034985: 8105-10-285
• 00887868034978: 8105-10-270
• 00887868034961: 8105-10-255
• 00887868034954: 8105-09-420
• 00887868034947: 8105-09-405
• 00887868034930: 8105-09-390
• 00887868034923: 8105-09-375