C-Fit & DC-Fit Acetabular Cup System 126.842P

GUDID 05055196910065

CFIT CUP METALBACK

CORIN LTD

Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell

• Primary Device ID: 05055196910065
• NIH Device Record Key: 73e8ce8d-eae3-46d0-9ae5-7cde16d2826d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-Fit & DC-Fit Acetabular Cup System
• Version Model Number: 126.842P
• Catalog Number: 126.842P
• 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
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com
• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055196910065 [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

[05055196910065]

Radiation Sterilization

[05055196910065]

Radiation Sterilization

[05055196910065]

Radiation Sterilization

[05055196910065]

Radiation Sterilization

[05055196910065]

Radiation Sterilization

[05055196910065]

Radiation Sterilization

[05055196910065]

Radiation Sterilization

[05055196910065]

Radiation Sterilization

[05055196910065]

Radiation Sterilization

[05055196910065]

Radiation Sterilization

[05055196910065]

Radiation Sterilization

[05055196910065]

Radiation Sterilization

[05055196910065]

Radiation Sterilization

[05055196910065]

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