G7 TYPE 1 PROVISIONAL HEAD 010002499

GUDID 00880304551442

Biomet Orthopedics, LLC

Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial

• Primary Device ID: 00880304551442
• NIH Device Record Key: 5d966387-c950-474e-8618-5a9cf018cb16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G7 TYPE 1 PROVISIONAL HEAD
• Version Model Number: 010002499
• Catalog Number: 010002499
• 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

Device Dimensions

• 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	00880304551442 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121874

FDA Product Code

• OQG: Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented

Sterilization

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

[00880304551442]

Moist Heat or Steam Sterilization

[00880304551442]

Moist Heat or Steam Sterilization

[00880304551442]

Moist Heat or Steam Sterilization

[00880304551442]

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 TYPE 1 PROVISIONAL HEAD]

• 00880304551442: 010002499
• 00880304551329: 010002485
• 00880304551305: 010002492