MODULAR PROVISIONAL LINER 424468

GUDID 00880304373730

Biomet Orthopedics, LLC

Acetabulum prosthesis trial, reusable

• Primary Device ID: 00880304373730
• NIH Device Record Key: 695a491d-09ca-4c72-9dde-e27d56d0d433
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MODULAR PROVISIONAL LINER
• Version Model Number: 424468
• Catalog Number: 424468
• 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
• 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 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	00880304373730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K911718

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

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

[00880304373730]

Moist Heat or Steam Sterilization

[00880304373730]

Moist Heat or Steam Sterilization

[00880304373730]

Moist Heat or Steam Sterilization

[00880304373730]

Moist Heat or Steam Sterilization

[00880304373730]

Moist Heat or Steam Sterilization

[00880304373730]

Moist Heat or Steam Sterilization

[00880304373730]

Moist Heat or Steam Sterilization

[00880304373730]

Moist Heat or Steam Sterilization

[00880304373730]

Moist Heat or Steam Sterilization

[00880304373730]

Moist Heat or Steam Sterilization

[00880304373730]

Moist Heat or Steam Sterilization

[00880304373730]

Moist Heat or Steam Sterilization

[00880304373730]

Moist Heat or Steam Sterilization

[00880304373730]

Moist Heat or Steam Sterilization

[00880304373730]

Moist Heat or Steam Sterilization

[00880304373730]

Moist Heat or Steam Sterilization

[00880304373730]

Moist Heat or Steam Sterilization

[00880304373730]

Moist Heat or Steam Sterilization

[00880304373730]

Moist Heat or Steam Sterilization

[00880304373730]

Moist Heat or Steam Sterilization

[00880304373730]

Moist Heat or Steam Sterilization

[00880304373730]

Moist Heat or Steam Sterilization

[00880304373730]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-10-28

On-Brand Devices [MODULAR PROVISIONAL LINER]

• 00880304373747: 424469
• 00880304373730: 424468
• 00880304373723: 424467
• 00880304373716: 424464
• 00880304373709: 424463
• 00880304373693: 424462
• 00880304373686: 424461
• 00880304373679: 424460
• 00880304373655: 424454
• 00880304373648: 424453
• 00880304373631: 424452
• 00880304373617: 424448
• 00880304373600: 424447
• 00880304373587: 424445