Echo® Bi-Metric® Microplasty® Hip Stem 110025587

GUDID 00887868469718

Biomet Orthopedics, LLC

Femoral stem prosthesis trial

• Primary Device ID: 00887868469718
• NIH Device Record Key: 6836d3d1-ceb6-488c-9b78-542865b4f8e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Echo® Bi-Metric® Microplasty® Hip Stem
• Version Model Number: 110025587
• Catalog Number: 110025587
• 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
• 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 Size Text, specify: 0
• 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	00887868469718 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143009

FDA Product Code

• LWJ: Prosthesis, hip, semi-constrained, metal/polymer, uncemented

Sterilization

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

[00887868469718]

Moist Heat or Steam Sterilization

[00887868469718]

Moist Heat or Steam Sterilization

[00887868469718]

Moist Heat or Steam Sterilization

[00887868469718]

Moist Heat or Steam Sterilization

[00887868469718]

Moist Heat or Steam Sterilization

[00887868469718]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-30
• Device Publish Date: 2022-06-22

On-Brand Devices [Echo® Bi-Metric® Microplasty® Hip Stem]

• 00887868513053: XR193108-4
• 00887868513046: XR193108-3
• 00887868513039: XR193108-2
• 00887868513022: XR193108-1
• 00887868513015: XR193107-4
• 00887868513008: XR193107-3
• 00887868512995: XR193107-2
• 00887868512988: XR193107-1
• 00887868512971: XR192907-4
• 00887868512964: XR192907-3
• 00887868512957: XR192907-2
• 00887868512940: XR192907-1
• 00887868469671: 110025583
• 00887868469664: 110025582
• 00887868469657: 110025581
• 00887868469640: 110025580
• 00887868469633: 110025579
• 00887868469626: 110025578
• 00887868469619: 110025577
• 00887868469602: 110025576
• 00887868469596: 110025575
• 00887868469589: 110025574
• 00887868469572: 110025573
• 00887868469558: 110025100
• 00887868469541: 110025088
• 00887868469848: 110025760
• 00887868469831: 110025759
• 00887868469824: 110025758
• 00887868469817: 110025757
• 00887868469800: 110025756
• 00887868469794: 110025755
• 00887868469718: 110025587
• 00887868469701: 110025586
• 00887868469695: 110025585
• 00887868469688: 110025584