COMPREHENSIVE® SRS / NEXEL 110029259

GUDID 00880304806085

Biomet Orthopedics, LLC

Elbow humerus prosthesis trial

• Primary Device ID: 00880304806085
• NIH Device Record Key: c5be0bc6-d844-402c-825f-ca0c381125af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMPREHENSIVE® SRS / NEXEL
• Version Model Number: 110029259
• Catalog Number: 110029259
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304806085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153398

FDA Product Code

• MBF: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Sterilization

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

[00880304806085]

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: 2016-02-22

On-Brand Devices [COMPREHENSIVE® SRS / NEXEL]

• 00880304806139: 110029943
• 00880304806122: 110029942
• 00880304806115: 110029941
• 00880304806108: 110029261
• 00880304806092: 110029260
• 00880304806085: 110029259
• 00880304806054: 110029940
• 00880304806047: 110029939
• 00880304806030: 110029938
• 00880304806023: 110029826
• 00880304806016: 110029825
• 00880304806009: 110029824