OSS LOW PROFILE FEMORAL TRIAL 110018657

GUDID 00880304678446

Biomet Orthopedics, LLC

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• Primary Device ID: 00880304678446
• NIH Device Record Key: 573cda15-74a8-4551-a647-e215a9b3b3d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSS LOW PROFILE FEMORAL TRIAL
• Version Model Number: 110018657
• Catalog Number: 110018657
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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
• 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
• 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	00880304678446 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142814

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

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

[00880304678446]

Moist Heat or Steam Sterilization

[00880304678446]

Moist Heat or Steam Sterilization

[00880304678446]

Moist Heat or Steam Sterilization

[00880304678446]

Moist Heat or Steam Sterilization

[00880304678446]

Moist Heat or Steam Sterilization

[00880304678446]

Moist Heat or Steam Sterilization

[00880304678446]

Moist Heat or Steam Sterilization

[00880304678446]

Moist Heat or Steam Sterilization

[00880304678446]

Moist Heat or Steam Sterilization

[00880304678446]

Moist Heat or Steam Sterilization

[00880304678446]

Moist Heat or Steam Sterilization

[00880304678446]

Moist Heat or Steam Sterilization

[00880304678446]

Moist Heat or Steam Sterilization

[00880304678446]

Moist Heat or Steam Sterilization

[00880304678446]

Moist Heat or Steam Sterilization

[00880304678446]

Moist Heat or Steam Sterilization

[00880304678446]

Moist Heat or Steam Sterilization

[00880304678446]

Moist Heat or Steam Sterilization

[00880304678446]

Moist Heat or Steam Sterilization

[00880304678446]

Moist Heat or Steam Sterilization

[00880304678446]

Moist Heat or Steam Sterilization

[00880304678446]

Moist Heat or Steam Sterilization

[00880304678446]

Moist Heat or Steam Sterilization

[00880304678446]

Moist Heat or Steam Sterilization

[00880304678446]

Moist Heat or Steam Sterilization

[00880304678446]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-24
• Device Publish Date: 2020-08-14

On-Brand Devices [OSS LOW PROFILE FEMORAL TRIAL]

• 00880304678446: 110018657
• 00880304678439: 110018656