b-ONE Hip Specialty 8819P00001

GUDID 00843575121219

Broach Box Chisel

B-ONE ORTHO, CORP.

Orthopaedic chisel

• Primary Device ID: 00843575121219
• NIH Device Record Key: f858fd90-2748-4a32-8fac-4a8b92ddb13a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: b-ONE Hip Specialty
• Version Model Number: 8819P00001
• Catalog Number: 8819P00001
• Company DUNS: 081315444
• Company Name: B-ONE ORTHO, CORP.
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843575121219 [Primary]

FDA Product Code

• HTS: Knife, Orthopedic

Sterilization

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

[00843575121219]

Moist Heat or Steam Sterilization

[00843575121219]

Moist Heat or Steam Sterilization

[00843575121219]

Moist Heat or Steam Sterilization

[00843575121219]

Moist Heat or Steam Sterilization

[00843575121219]

Moist Heat or Steam Sterilization

[00843575121219]

Moist Heat or Steam Sterilization

[00843575121219]

Moist Heat or Steam Sterilization

[00843575121219]

Moist Heat or Steam Sterilization

[00843575121219]

Moist Heat or Steam Sterilization

[00843575121219]

Moist Heat or Steam Sterilization

[00843575121219]

Moist Heat or Steam Sterilization

[00843575121219]

Moist Heat or Steam Sterilization

[00843575121219]

Moist Heat or Steam Sterilization

[00843575121219]

Moist Heat or Steam Sterilization

[00843575121219]

Moist Heat or Steam Sterilization

[00843575121219]

Moist Heat or Steam Sterilization

[00843575121219]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-30
• Device Publish Date: 2025-01-22

Devices Manufactured by B-ONE ORTHO, CORP.

• 00843575127143 - MOBIO™ Total Knee System: 2026-03-16 PS TIBIAL INSERT,SIZE BC/3-6 9MM thickness, Standard UHMWPE
• 00843575127150 - MOBIO™ Total Knee System: 2026-03-16 PS TIBIAL INSERT,SIZE BC/3-6 10MM thickness, Standard UHMWPE
• 00843575127167 - MOBIO™ Total Knee System: 2026-03-16 PS TIBIAL INSERT,SIZE BC/3-6 11MM thickness, Standard UHMWPE
• 00843575127174 - MOBIO™ Total Knee System: 2026-03-16 PS TIBIAL INSERT,SIZE BC/3-6 13MM thickness, Standard UHMWPE
• 00843575127181 - MOBIO™ Total Knee System: 2026-03-16 PS TIBIAL INSERT,SIZE BC/3-6 16MM thickness, Standard UHMWPE
• 00843575127198 - MOBIO™ Total Knee System: 2026-03-16 PS TIBIAL INSERT,SIZE BC/3-6 19MM thickness, Standard UHMWPE
• 00843575127204 - MOBIO™ Total Knee System: 2026-03-16 PS TIBIAL INSERT,SIZE BC/3-6 22MM thickness, Standard UHMWPE
• 00843575127211 - MOBIO™ Total Knee System: 2026-03-16 PS TIBIAL INSERT,SIZE BC/3-6 25MM thickness, Standard UHMWPE