Wedge Bur, Sterile 975-002

GUDID 00857676008706

Eca Medical Instruments

Orthopaedic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00857676008706
• NIH Device Record Key: 0fe9e3b9-6317-400f-92d9-568b89177c50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wedge Bur, Sterile
• Version Model Number: 3.1MM x 13 MM
• Catalog Number: 975-002
• Company DUNS: 084330422
• Company Name: Eca Medical Instruments
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857676008706 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-11
• Device Publish Date: 2025-03-03

Devices Manufactured by Eca Medical Instruments

• 00857676008232 - Stryker: 2025-04-10
• 00857676008737 - TruTorq Adaptor Sterile, Single Use: 2025-03-17
• 00857676008676 - Revcon Instrument Kit, Sterile: 2025-03-11
• 00857676008683 - Revcon Instrument Kit, Sterile: 2025-03-11
• 00857676008690 - Shannon Bur, Sterile: 2025-03-11
• 00857676008706 - Wedge Bur, Sterile: 2025-03-11
• 00857676008706 - Wedge Bur, Sterile: 2025-03-11
• 00857676008638 - Threaded Trimmable Fixation Nail Instrument Pack 5.5: 2024-10-29
• 00857676008201 - TruFIX: 2024-07-25