COMPREHENSIVE(R) SHOULDER SYSTEM 31-406901

GUDID 00880304431904

Biomet Orthopedics, LLC

Surgical instrument handle, non-torque-limiting Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00880304431904
• NIH Device Record Key: 0319886f-9470-44b4-a90f-98ca37ecf09c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMPREHENSIVE(R) SHOULDER SYSTEM
• Version Model Number: 31-406901
• Catalog Number: 31-406901
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304431904 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193038

FDA Product Code

• KWT: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[00880304431904]

Moist Heat or Steam Sterilization

[00880304431904]

Moist Heat or Steam Sterilization

[00880304431904]

Moist Heat or Steam Sterilization

[00880304431904]

Moist Heat or Steam Sterilization

[00880304431904]

Moist Heat or Steam Sterilization

[00880304431904]

Moist Heat or Steam Sterilization

[00880304431904]

Moist Heat or Steam Sterilization

[00880304431904]

Moist Heat or Steam Sterilization

[00880304431904]

Moist Heat or Steam Sterilization

[00880304431904]

Moist Heat or Steam Sterilization

[00880304431904]

Moist Heat or Steam Sterilization

[00880304431904]

Moist Heat or Steam Sterilization

[00880304431904]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-08-09
• Device Publish Date: 2017-07-28

On-Brand Devices [COMPREHENSIVE(R) SHOULDER SYSTEM]

• 00880304431904: 31-406901
• 00880304367029: 406997
• 00880304367005: 406995
• 00880304009592: 406994