G7 PROVISIONAL SHELL 010002457

GUDID 00880304564541

Biomet Orthopedics, LLC

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• Primary Device ID: 00880304564541
• NIH Device Record Key: 35da94ab-a2b4-4729-81b7-2d6d6584aa34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G7 PROVISIONAL SHELL
• Version Model Number: 010002457
• Catalog Number: 010002457
• 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

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 Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304564541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121874

FDA Product Code

• OQI: Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented

Sterilization

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

[00880304564541]

Moist Heat or Steam Sterilization

[00880304564541]

Moist Heat or Steam Sterilization

[00880304564541]

Moist Heat or Steam Sterilization

[00880304564541]

Moist Heat or Steam Sterilization

[00880304564541]

Moist Heat or Steam Sterilization

[00880304564541]

Moist Heat or Steam Sterilization

[00880304564541]

Moist Heat or Steam Sterilization

[00880304564541]

Moist Heat or Steam Sterilization

[00880304564541]

Moist Heat or Steam Sterilization

[00880304564541]

Moist Heat or Steam Sterilization

[00880304564541]

Moist Heat or Steam Sterilization

[00880304564541]

Moist Heat or Steam Sterilization

[00880304564541]

Moist Heat or Steam Sterilization

[00880304564541]

Moist Heat or Steam Sterilization

[00880304564541]

Moist Heat or Steam Sterilization

[00880304564541]

Moist Heat or Steam Sterilization

[00880304564541]

Moist Heat or Steam Sterilization

[00880304564541]

Moist Heat or Steam Sterilization

[00880304564541]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-10-26

On-Brand Devices [G7 PROVISIONAL SHELL]

• 00880304564770: 010002480
• 00880304564732: 010002476
• 00880304564688: 010002471
• 00880304564664: 010002469
• 00880304564640: 010002467
• 00880304564626: 010002465
• 00880304564602: 010002463
• 00880304564589: 010002461
• 00880304564565: 010002459
• 00880304564541: 010002457
• 00880304564527: 010002455
• 00880304564503: 010002453
• 00880304564480: 010002451
• 00880304564466: 010002449
• 00880304564442: 010002447
• 00880304564428: 010002445
• 00880304564404: 010002443