BiMobile Dual Mobility System Instrument

GUDID 04026575439478

Impaction Expander, full metal version, Ø 70 mm

WALDEMAR LINK GmbH & Co. KG

Orthopaedic implant impactor

• Primary Device ID: 04026575439478
• NIH Device Record Key: 8180c030-6187-4896-8365-75c4949ed40b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BiMobile Dual Mobility System Instrument
• Version Model Number: 184-354/70
• 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	04026575439478 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211567

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

[04026575439478]

Moist Heat or Steam Sterilization

[04026575439478]

Moist Heat or Steam Sterilization

[04026575439478]

Moist Heat or Steam Sterilization

[04026575439478]

Moist Heat or Steam Sterilization

[04026575439478]

Moist Heat or Steam Sterilization

[04026575439478]

Moist Heat or Steam Sterilization

[04026575439478]

Moist Heat or Steam Sterilization

[04026575439478]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-29
• Device Publish Date: 2022-06-21

On-Brand Devices [BiMobile Dual Mobility System Instrument]

• 04026575439478: Impaction Expander, full metal version, Ø 70 mm
• 04026575439461: Impaction Expander, full metal version, Ø 68 mm
• 04026575439454: Impaction Expander, full metal version, Ø 66 mm
• 04026575439447: Impaction Expander, full metal version, Ø 64 mm
• 04026575439430: Impaction Expander, full metal version, Ø 62 mm
• 04026575439423: Impaction Expander, full metal version, Ø 60 mm
• 04026575439416: Impaction Expander, full metal version, Ø 58 mm
• 04026575439409: Impaction Expander, full metal version, Ø 56 mm
• 04026575439393: Impaction Expander, full metal version, Ø 54 mm
• 04026575439386: Impaction Expander, full metal version, Ø 52 mm
• 04026575439379: Impaction Expander, full metal version, Ø 50 mm
• 04026575439362: Impaction Expander, full metal version, Ø 48 mm
• 04026575439355: Impaction Expander, full metal version, Ø 46 mm
• 04026575439348: Impaction Expander, full metal version, Ø 44 mm
• 04026575439331: Impaction Expander, full metal version, Ø 42 mm
• 04026575439324: Impactor Handle
• 04026575439317: Alignment Guide