G7 TYPE 12 / 14 PROVISIONAL HEAD 010002538

GUDID 00880304565128

Biomet Orthopedics, LLC

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

• Primary Device ID: 00880304565128
• NIH Device Record Key: 6a2b487e-f012-4fd5-879d-086499367fad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G7 TYPE 12 / 14 PROVISIONAL HEAD
• Version Model Number: 010002538
• Catalog Number: 010002538
• 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	00880304565128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121874

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

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

[00880304565128]

Moist Heat or Steam Sterilization

[00880304565128]

Moist Heat or Steam Sterilization

[00880304565128]

Moist Heat or Steam Sterilization

[00880304565128]

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: 2016-10-26

On-Brand Devices [G7 TYPE 12 / 14 PROVISIONAL HEAD]

• 00880304565159: 010002541
• 00880304565142: 010002540
• 00880304565135: 010002539
• 00880304565128: 010002538
• 00880304565111: 010002537
• 00880304565104: 010002536
• 00880304565098: 010002535
• 00880304565081: 010002534
• 00880304565050: 010002531
• 00880304565234: 010002549
• 00880304565227: 010002548
• 00880304565210: 010002547
• 00880304565203: 010002546