PRIMO™ Acetabular Cup System 8819910200

GUDID 00843575124388

Acetabular Screw Instrument Tray

B-ONE ORTHO, CORP.

Surgical instrument/implant rack

• Primary Device ID: 00843575124388
• NIH Device Record Key: da69be00-54f6-40b6-9299-e743d770f804
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRIMO™ Acetabular Cup System
• Version Model Number: 8819910200
• Catalog Number: 8819910200
• 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	00843575124388 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00843575124388]

Moist Heat or Steam Sterilization

[00843575124388]

Moist Heat or Steam Sterilization

[00843575124388]

Moist Heat or Steam Sterilization

[00843575124388]

Moist Heat or Steam Sterilization

[00843575124388]

Moist Heat or Steam Sterilization

[00843575124388]

Moist Heat or Steam Sterilization

[00843575124388]

Moist Heat or Steam Sterilization

[00843575124388]

Moist Heat or Steam Sterilization

[00843575124388]

Moist Heat or Steam Sterilization

[00843575124388]

Moist Heat or Steam Sterilization

[00843575124388]

Moist Heat or Steam Sterilization

[00843575124388]

Moist Heat or Steam Sterilization

[00843575124388]

Moist Heat or Steam Sterilization

[00843575124388]

Moist Heat or Steam Sterilization

[00843575124388]

Moist Heat or Steam Sterilization

[00843575124388]

Moist Heat or Steam Sterilization

[00843575124388]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-19
• Device Publish Date: 2026-02-11

On-Brand Devices [PRIMO™ Acetabular Cup System]

• 00843575124449: PRIMO Liner Trials Tray
• 00843575124388: Acetabular Screw Instrument Tray