Double Mobility Liner

GUDID 07630030806827

PE Liner 22 / DMC

Medacta International SA

Non-constrained polyethylene acetabular liner

• Primary Device ID: 07630030806827
• NIH Device Record Key: 8a59bc1d-dd66-4ed7-b098-1283c8f71e69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Double Mobility Liner
• Version Model Number: 01.26.2246M
• Company DUNS: 488227125
• Company Name: Medacta International SA
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	07630030806827 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083116

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-11-18

On-Brand Devices [Double Mobility Liner ]

• 07630030807534: HC PE Liner 28 / DMN
• 07630030807527: PE Liner 28 / DMN
• 07630030807503: HC PE Liner 28 / DMM
• 07630030807497: PE Liner 28 / DMM
• 07630030807473: HC PE Liner 28 / DML
• 07630030807466: PE Liner 28 / DML
• 07630030807442: HC PE Liner 28 / DMI
• 07630030807435: PE Liner 28 / DMI
• 07630030807411: HC PE Liner 28 / DMH
• 07630030807404: PE Liner 28 / DMH
• 07630030807381: HC PE Liner 28 / DMG
• 07630030807374: PE Liner 28 / DMG
• 07630030807343: HC PE Liner 28 / DMF
• 07630030807336: PE Liner 28 / DMF
• 07630030807282: HC PE Liner 28 / DME
• 07630030807275: PE Liner 28 / DME
• 07630030807244: HC PE Liner 28 / DMD
• 07630030807237: PE Liner 28 / DMD
• 07630030807022: HC PE Liner 22 / DMN
• 07630030807015: PE Liner 22 / DMN
• 07630030807008: HC PE Liner 22 / DMM
• 07630030806995: PE Liner 22 / DMM
• 07630030806988: HC PE Liner 22 / DML
• 07630030806971: PE Liner 22 / DML
• 07630030806964: HC PE Liner 22 / DMI
• 07630030806957: PE Liner 22 / DMI
• 07630030806940: HC PE Liner 22 / DMH
• 07630030806933: PE Liner 22 / DMH
• 07630030806926: HC PE Liner 22 / DMG
• 07630030806919: PE Liner 22 / DMG
• 07630030806902: HC PE Liner 22 / DMF
• 07630030806896: PE Liner 22 / DMF
• 07630030806889: HC PE Liner 22 / DME
• 07630030806872: PE Liner 22 / DME
• 07630030806865: HC PE Liner 22 / DMD
• 07630030806858: PE Liner 22 / DMD
• 07630030806834: HC PE Liner 22 / DMC
• 07630030806827: PE Liner 22 / DMC
• 07630030806803: HC PE Liner 22 / DMB
• 07630030806797: PE Liner 22 / DMB
• 07630030806780: HC PE Liner 22 / DMA
• 07630030806773: PE Liner 22 / DMA