ELME ST231878D

GUDID 00842180195899

Lombardi Gap Balancing Femoral Tibial Spreader, Large – Diamond Cut Pads, Overall Length: 9.25" (23,5 cm), Pads: 22 mm x 13 mm, Opens to: 50 mm

ELMED INCORPORATED

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00842180195899
• NIH Device Record Key: 99a1fa43-2457-47e5-8c7c-fce3aa7893c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELME
• Version Model Number: ST231878D
• Catalog Number: ST231878D
• Company DUNS: 049290364
• Company Name: ELMED INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com
• Phone: 224-353-6446
• Email: medical@elmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842180195899 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00842180195899]

Moist Heat or Steam Sterilization

[00842180195899]

Moist Heat or Steam Sterilization

[00842180195899]

Moist Heat or Steam Sterilization

[00842180195899]

Moist Heat or Steam Sterilization

[00842180195899]

Moist Heat or Steam Sterilization

[00842180195899]

Moist Heat or Steam Sterilization

[00842180195899]

Moist Heat or Steam Sterilization

[00842180195899]

Moist Heat or Steam Sterilization

[00842180195899]

Moist Heat or Steam Sterilization

[00842180195899]

Moist Heat or Steam Sterilization

[00842180195899]

Moist Heat or Steam Sterilization

[00842180195899]

Moist Heat or Steam Sterilization

[00842180195899]

Moist Heat or Steam Sterilization

[00842180195899]

Moist Heat or Steam Sterilization

[00842180195899]

Moist Heat or Steam Sterilization

[00842180195899]

Moist Heat or Steam Sterilization

[00842180195899]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-25
• Device Publish Date: 2024-04-17

On-Brand Devices [ELME]

• 00842180163362: Lombardi Gap Balancing Femoral Tibial Spreader, Large – Diamond Cut Pads, Overall Length: 9.25
• 00842180195899: Lombardi Gap Balancing Femoral Tibial Spreader, Large – Diamond Cut Pads, Overall Length: 9.25