COMPRESS / SRS INSTRUMENT 110004098

GUDID 00880304566835

Biomet Orthopedics, LLC

Humeral head prosthesis trial, reusable

• Primary Device ID: 00880304566835
• NIH Device Record Key: 1b79665c-3147-47fb-aa0b-e332ad13eaa0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMPRESS / SRS INSTRUMENT
• Version Model Number: 110004098
• Catalog Number: 110004098
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304566835 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123297

FDA Product Code

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

Sterilization

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

[00880304566835]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-10-28

On-Brand Devices [COMPRESS / SRS INSTRUMENT]

• 00880304566835: 110004098
• 00880304566828: 110004097