TRAUMA FIXATION SYSTEM 345216

GUDID 00880304357327

Biomet Orthopedics, LLC

Bone nail end-cap, sterile Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap

• Primary Device ID: 00880304357327
• NIH Device Record Key: 6936b698-4df3-4f10-b721-30c0a9f02b9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRAUMA FIXATION SYSTEM
• Version Model Number: 345216
• Catalog Number: 345216
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304357327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982953

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: 4
• Public Version Date: 2018-10-22
• Device Publish Date: 2015-10-24

On-Brand Devices [TRAUMA FIXATION SYSTEM]

• 00880304357327: 345216
• 00880304357303: 345215
• 00880304357266: 345165
• 00880304357259: 345160
• 00880304357235: 345145
• 00880304357211: 345140
• 00880304357198: 345125
• 00880304357174: 345120
• 00880304289635: 245972
• 00880304289628: 245970
• 00880304289611: 245968
• 00880304289598: 245964
• 00880304289581: 245962
• 00880304289550: 245956
• 00880304289543: 245954
• 00880304289536: 245952
• 00880304289529: 245950
• 00880304289505: 245946
• 00880304289475: 245942
• 00880304289468: 245940
• 00880304289451: 245938
• 00880304289444: 245936
• 00880304289413: 245930
• 00880304289390: 245926
• 00880304289383: 245924
• 00880304289376: 245922
• 00880304289369: 245920
• 00880304289352: 245918
• 00880304289307: 245908
• 00880304289291: 245906
• 00880304289284: 245904
• 00880304289277: 245902
• 00880304289222: 245860
• 00880304289208: 245856
• 00880304289192: 245854
• 00880304289154: 245848
• 00880304289147: 245846
• 00880304289086: 245840
• 00880304289055: 245836
• 00880304289017: 245830
• 00880304289000: 245828
• 00880304288997: 245826
• 00880304288973: 245824
• 00880304083875: CP400181
• 00880304083349: CP300156