C-Fit & DC-Fit Acetabular Cup System 152.522

GUDID 05055196911710

DCFIT CUP INSERT OFF

CORIN LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 05055196911710
• NIH Device Record Key: 2cb1d1be-040d-4df1-887c-d8a745796251
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-Fit & DC-Fit Acetabular Cup System
• Version Model Number: 152.522
• Catalog Number: 152.522
• Company DUNS: 295437313
• Company Name: CORIN LTD
• 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: 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

Customer Support Contacts

• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055196911710 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972995

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

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

[05055196911710]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-17

On-Brand Devices [C-Fit & DC-Fit Acetabular Cup System]

• 05055196972971: DCFIT CUP INSERT STD
• 05055196972964: DCFIT CUP INSERT STD
• 05055196972957: DCFIT CUP INSERT STD
• 05055196941243: DCFIT CUP INSERT OFF
• 05055196941236: DCFIT CUP INSERT OFF
• 05055196941229: DCFIT CUP INSERT OFF
• 05055196941212: DCFIT CUP INSERT STD
• 05055196941205: DCFIT CUP INSERT STD
• 05055196941199: DCFIT CUP INSERT STD
• 05055196941182: DCFIT CUP INSERT STD
• 05055196941175: DCFIT CUP INSERT STD
• 05055196941168: DCFIT CUP INSERT STD
• 05055196941151: DCFIT CUP INSERT STD
• 05055196941144: DCFIT CUP INSERT STD
• 05055196941137: DCFIT CUP INSERT STD
• 05055196941120: DCFIT CUP INSERT STD
• 05055196941113: DCFIT CUP INSERT STD
• 05055196941106: DCFIT CUP INSERT STD
• 05055196941083: DCFIT CUP INSERT STD
• 05055196941076: DCFIT CUP INSERT STD
• 05055196941069: DCFIT CUP INSERT STD
• 05055196941014: DC FIT CEMENTED CUP
• 05055196940987: DCFIT CUP METALBACK
• 05055196940970: DCFIT CUP METALBACK
• 05055196940963: DCFIT CUP METALBACK
• 05055196940956: DC FIT CEMENTED CUP
• 05055196940925: DCFIT CUP METALBACK
• 05055196940918: DCFIT CUP METALBACK
• 05055196940888: DCFIT CUP METALBACK
• 05055196940871: DCFIT CUP METALBACK
• 05055196940826: DCFIT CUP METALBACK
• 05055196940819: DCFIT CUP METALBACK
• 05055196940765: DCFIT CUP METALBACK
• 05055196940758: DCFIT CUP METALBACK
• 05055196940703: DCFIT CUP METALBACK
• 05055196940697: DCFIT CUP METALBACK
• 05055196940642: DCFIT CUP METALBACK
• 05055196940635: DCFIT CUP METALBACK
• 05055196935068: CFIT CUP METALBACK
• 05055196921313: BONE SCREW
• 05055196921306: BONE SCREW
• 05055196921290: BONE SCREW
• 05055196921283: CANCELLOUS SCREW
• 05055196921276: CANCELLOUS SCREW
• 05055196921269: CANCELLOUS SCREW
• 05055196921252: CANCELLOUS SCREW
• 05055196921245: CANCELLOUS SCREW
• 05055196921238: CANCELLOUS SCREW
• 05055196921221: CANCELLOUS SCREW
• 05055196913967: CFIT CUP INSERT NEUT