PHOENIX TIBIAL NAIL SYSTEM 40028

GUDID 00880304519855

Biomet Orthopedics, LLC

Tibia nail, sterile Tibia nail Tibia nail Tibia nail Tibia nail Tibia nail Tibia nail Tibia nail Tibia nail

• Primary Device ID: 00880304519855
• NIH Device Record Key: 2cb9260a-a1ef-4145-a795-4375f4ffb0c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHOENIX TIBIAL NAIL SYSTEM
• Version Model Number: 40028
• Catalog Number: 40028
• 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: 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(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• 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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304519855 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063570

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

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 [PHOENIX TIBIAL NAIL SYSTEM]

• 00880304538887: 40930
• 00880304533714: 40629
• 00880304533707: 40029
• 00880304533158: 40027
• 00880304521568: 40039
• 00880304520479: 40035
• 00880304520035: 40041
• 00880304520004: 40641
• 00880304519992: 40325
• 00880304519862: 40327
• 00880304519855: 40028
• 00880304516496: 40037
• 00880304516489: 40030
• 00880304516243: 40329
• 00880304516236: 40624
• 00880304516229: 40929
• 00880304516205: 40326
• 00880304515970: 40032
• 00880304515925: 40631
• 00880304515918: 40626
• 00880304515901: 40633
• 00880304515895: 40341
• 00880304515376: 40936
• 00880304515369: 40938
• 00880304514539: 40932
• 00880304514423: 40924
• 00880304511293: 40330
• 00880304509979: 40033
• 00880304509689: 40038
• 00880304509221: 40042
• 00880304508798: 40334
• 00880304508408: 40024
• 00880304508392: 40036
• 00880304508385: 40040
• 00880304508323: 40628
• 00880304508316: 40333
• 00880304508187: 40637
• 00880304508163: 40026
• 00880304507944: 40337
• 00880304507890: 40339
• 00880304507883: 40639
• 00880304507821: 40338
• 00880304507067: 40940
• 00880304507050: 40934
• 00880304505919: 40328
• 00880304505902: 40034
• 00880304505773: 40630
• 00880304505155: 40331
• 00880304505148: 40335
• 00880304505131: 40336