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.

• 00843575120328 - Kosmo Femoral Hip System: 2025-04-15 BROACH, Size 0
• 00843575120335 - Kosmo Femoral Hip System: 2025-04-15 BROACH, Size 4.5
• 00843575120342 - Kosmo Femoral Hip System: 2025-04-15 BROACH, Size 10
• 00843575120359 - Kosmo Femoral Hip System: 2025-04-15 Cement Restrictor Trial, 7.75mm O.D.
• 00843575120366 - Kosmo Femoral Hip System: 2025-04-15 Cement Restrictor Trial, 9.25mm O.D.
• 00843575120373 - Kosmo Femoral Hip System: 2025-04-15 Cement Restrictor Trial, 11.25mm O.D.
• 00843575120380 - Kosmo Femoral Hip System: 2025-04-15 Cement Restrictor Trial 13.25mm O.D.
• 00843575120397 - Kosmo Femoral Hip System: 2025-04-15 Cement Restrictor Trial 15.25mm O.D.