INTEGRATED SHOULDER SYSTEM 490309125

GUDID 00880304008755

Biomet Orthopedics, LLC

Coated shoulder humeral stem prosthesis

• Primary Device ID: 00880304008755
• NIH Device Record Key: 02e2786e-f135-4b3f-9e9e-c3a420786200
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTEGRATED SHOULDER SYSTEM
• Version Model Number: 490309125
• Catalog Number: 490309125
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304008755 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961260

FDA Product Code

• KWT: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [INTEGRATED SHOULDER SYSTEM]

• 00880304387478: 490715125
• 00880304387461: 490614125
• 00880304387454: 490512125
• 00880304387447: 490411125
• 00880304387430: 490207125
• 00880304387423: 490106125
• 00880304378209: 450732051
• 00880304378186: 450628049
• 00880304378179: 450422045
• 00880304378155: 450320043
• 00880304378117: 450115038
• 00880304377028: 441000010
• 00880304195912: 10804
• 00880304195844: 10801
• 00880304008755: 490309125
• 00880304008748: 450524047
• 00880304008731: 450217041
• 00880304005136: 10805
• 00880304004870: 10803