b-ONE Hip Instrumentation 8819084000

GUDID 00843575106674

Curved Inserter, Non-Modular

B-ONE ORTHO, CORP.

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 00843575106674
• NIH Device Record Key: fac95d2e-87ae-4a95-9e17-fbea767c17fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: b-ONE Hip Instrumentation
• Version Model Number: 8819084000
• Catalog Number: 8819084000
• 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	00843575106674 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00843575106674]

Moist Heat or Steam Sterilization

[00843575106674]

Moist Heat or Steam Sterilization

[00843575106674]

Moist Heat or Steam Sterilization

[00843575106674]

Moist Heat or Steam Sterilization

[00843575106674]

Moist Heat or Steam Sterilization

[00843575106674]

Moist Heat or Steam Sterilization

[00843575106674]

Moist Heat or Steam Sterilization

[00843575106674]

Moist Heat or Steam Sterilization

[00843575106674]

Moist Heat or Steam Sterilization

[00843575106674]

Moist Heat or Steam Sterilization

[00843575106674]

Moist Heat or Steam Sterilization

[00843575106674]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-23
• Device Publish Date: 2020-09-15

On-Brand Devices [b-ONE Hip Instrumentation ]

• 00843575106650: Left Dual Offset Broach Handle
• 00843575106643: Right Dual Offset Broach Handle
• 00843575108623: b-ONE Instrument Tray, Main Body
• 00843575108616: b-ONE Instrument Tray
• 00843575106711: Offset Rasp
• 00843575106704: Starter Broach
• 00843575106698: Stem Remover, Non-Modular
• 00843575106681: Offset Cookie Cutter
• 00843575106674: Curved Inserter, Non-Modular
• 00843575106667: Straight Stem Impactor, Non-Modular
• 00843575124371: Half Tray Lid
• 00843575124364: Half Tray Outer Case