Bi-Polar/Endo 31-479564

GUDID 00887868481604

Biomet Orthopedics, LLC

Femoral head prosthesis trial

• Primary Device ID: 00887868481604
• NIH Device Record Key: 743eceaa-5130-47d0-9075-a8aec80bc58a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bi-Polar/Endo
• Version Model Number: 31-479564
• Catalog Number: 31-479564
• 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: 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
• 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
• 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
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868481604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051569

FDA Product Code

• MEH: Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

Sterilization

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

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

[00887868481604]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-11
• Device Publish Date: 2022-04-02

On-Brand Devices [Bi-Polar/Endo]

• 00887868481451: 31-479285
• 00887868481611: 31-479565
• 00887868481604: 31-479564
• 00887868481598: 31-479563
• 00887868481581: 31-479562
• 00887868481574: 31-479561
• 00887868481567: 31-479560
• 00887868481550: 31-479559
• 00887868481543: 31-479558
• 00887868481536: 31-479557
• 00887868481529: 31-479556
• 00887868481512: 31-479555
• 00887868481505: 31-479554
• 00887868481499: 31-479553
• 00887868481482: 31-479552
• 00887868481475: 31-479551
• 00887868481628: 31-479568