MobileLink Acetabular Cup System - Instruments

GUDID 04026575208401

Orthopaedic implant inserter/extractor, reusable - MobileLink Acetabular Cup System

WALDEMAR LINK GmbH & Co. KG

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 04026575208401
• NIH Device Record Key: 23a619fe-9f59-46ba-b2c2-a52c876b374c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MobileLink Acetabular Cup System - Instruments
• Version Model Number: 183-169/02
• 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	04026575208401 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200607

FDA Product Code

• OQG: Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented

Sterilization

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

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

[04026575208401]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-05
• Device Publish Date: 2023-04-27

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• 04026575180202: Fluted surgical drill bit, reusable - General instrument
• 04026575436606: Sterilization/disinfection container - General instrument
• 04026575433377: Surgical instrument handle, non-torque-limiting - MobileLink Acetabular Cup System
• 04026575274222: Surgical implant handling forceps - MobileLink Acetabular Cup System
• 04026575208401: Orthopaedic implant inserter/extractor, reusable - MobileLink Acetabular Cup System
• 04026575192373: Orthopaedic implant impactor - MobileLink Acetabular Cup System
• 04026575224623: Orthopaedic implant aiming/guiding block, reusable - General instrument