BiMobile Dual Mobility System - Instruments

GUDID 04026575279609

Orthopaedic prosthesis instrument, reusable - General Instrument

WALDEMAR LINK GmbH & Co. KG

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 04026575279609
• NIH Device Record Key: cc82bfd7-3a8b-463b-9eee-767cd72e0352
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BiMobile Dual Mobility System - Instruments
• Version Model Number: 184-352/60
• 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	04026575279609 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190535

FDA Product Code

• MEH: Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

Sterilization

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

[04026575279609]

Moist Heat or Steam Sterilization

[04026575279609]

Moist Heat or Steam Sterilization

[04026575279609]

Moist Heat or Steam Sterilization

[04026575279609]

Moist Heat or Steam Sterilization

[04026575279609]

Moist Heat or Steam Sterilization

[04026575279609]

Moist Heat or Steam Sterilization

[04026575279609]

Moist Heat or Steam Sterilization

[04026575279609]

Moist Heat or Steam Sterilization

[04026575279609]

Moist Heat or Steam Sterilization

[04026575279609]

Moist Heat or Steam Sterilization

[04026575279609]

Moist Heat or Steam Sterilization

[04026575279609]

Moist Heat or Steam Sterilization

[04026575279609]

Moist Heat or Steam Sterilization

[04026575279609]

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
• 04026575241903: Orthopaedic chisel - BiMobile Dual Mobility System