MobileLink Acetabular Cup System 183-852/28

GUDID 04026575189595

E-Dur® Insert - neutral with offset

WALDEMAR LINK GmbH & Co. KG

Non-constrained polyethylene acetabular liner

• Primary Device ID: 04026575189595
• NIH Device Record Key: 1cf21e10-98b7-4f3d-93cf-d6fa51df3395
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MobileLink Acetabular Cup System
• Version Model Number: 183-852/28
• Catalog Number: 183-852/28
• Company DUNS: 315675488
• Company Name: WALDEMAR LINK GmbH & Co. KG
• Device Count: 1
• DM Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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	04026575189595 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182321

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-17
• Device Publish Date: 2019-09-09

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