BiMobile Dual Mobility System - Instruments

GUDID 04026575279623

Orthopaedic prosthesis instrument, reusable - General Instrument

WALDEMAR LINK GmbH & Co. KG

Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 04026575279623
• NIH Device Record Key: d7c52501-69ed-483b-bd69-24e02f7de61d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BiMobile Dual Mobility System - Instruments
• Version Model Number: 184-352/64
• Company DUNS: 315675488
• Company Name: WALDEMAR LINK GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	04026575279623 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190535

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

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

[04026575279623]

Moist Heat or Steam Sterilization

[04026575279623]

Moist Heat or Steam Sterilization

[04026575279623]

Moist Heat or Steam Sterilization

[04026575279623]

Moist Heat or Steam Sterilization

[04026575279623]

Moist Heat or Steam Sterilization

[04026575279623]

Moist Heat or Steam Sterilization

[04026575279623]

Moist Heat or Steam Sterilization

[04026575279623]

Moist Heat or Steam Sterilization

[04026575279623]

Moist Heat or Steam Sterilization

[04026575279623]

Moist Heat or Steam Sterilization

[04026575279623]

Moist Heat or Steam Sterilization

[04026575279623]

Moist Heat or Steam Sterilization

[04026575279623]

Moist Heat or Steam Sterilization

[04026575279623]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-03
• Device Publish Date: 2023-01-25

On-Brand Devices [BiMobile Dual Mobility System - Instruments]

• 04026575298730: Acetabulum prosthesis trial, reusable - General instrument
• 04026575279654: Orthopaedic prosthesis instrument, reusable - General Instrument
• 04026575279647: Orthopaedic prosthesis instrument, reusable - General Instrument
• 04026575279630: Orthopaedic prosthesis instrument, reusable - General Instrument
• 04026575279623: Orthopaedic prosthesis instrument, reusable - General Instrument
• 04026575279616: Orthopaedic prosthesis instrument, reusable - General Instrument
• 04026575279609: Orthopaedic prosthesis instrument, reusable - General Instrument
• 04026575279593: Orthopaedic prosthesis instrument, reusable - General Instrument
• 04026575279586: Orthopaedic prosthesis instrument, reusable - General Instrument
• 04026575279579: Orthopaedic prosthesis instrument, reusable - General Instrument
• 04026575279562: Orthopaedic prosthesis instrument, reusable - General Instrument
• 04026575279555: Orthopaedic prosthesis instrument, reusable - General Instrument
• 04026575279548: Orthopaedic prosthesis instrument, reusable - General Instrument
• 04026575279531: Orthopaedic prosthesis instrument, reusable - General Instrument
• 04026575279524: Orthopaedic prosthesis instrument, reusable - General Instrument
• 04026575279517: Orthopaedic prosthesis instrument, reusable - General Instrument