Corin BiPolar-i 1110958

GUDID 05056139234491

Corin BiPolar-i Ø58/28mm

CORIN LTD

Femoral head bipolar component Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty

• Primary Device ID: 05056139234491
• NIH Device Record Key: 3df0ef2d-6586-4a16-a905-ad5720874a0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Corin BiPolar-i
• Version Model Number: 1110958
• Catalog Number: 1110958
• Company DUNS: 295437313
• Company Name: CORIN LTD
• 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	05056139234491 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183114

FDA Product Code

• KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Sterilization

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

[05056139234491]

Radiation Sterilization

[05056139234491]

Radiation Sterilization

[05056139234491]

Radiation Sterilization

[05056139234491]

Radiation Sterilization

[05056139234491]

Radiation Sterilization

[05056139234491]

Radiation Sterilization

[05056139234491]

Radiation Sterilization

[05056139234491]

Radiation Sterilization

[05056139234491]

Radiation Sterilization

[05056139234491]

Radiation Sterilization

[05056139234491]

Radiation Sterilization

[05056139234491]

Radiation Sterilization

[05056139234491]

Radiation Sterilization

[05056139234491]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-24
• Device Publish Date: 2019-07-16

On-Brand Devices [Corin BiPolar-i]

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• 05056139234569: Corin BiPolar-i Ø42/22mm
• 05056139234552: Corin BiPolar-i Ø41/22mm
• 05056139234545: Corin BiPolar-i Ø40/22mm
• 05056139234538: Corin BiPolar-i Ø62/28mm
• 05056139234521: Corin BiPolar-i Ø61/28mm
• 05056139234514: Corin BiPolar-i Ø60/28mm
• 05056139234507: Corin BiPolar-i Ø59/28mm
• 05056139234491: Corin BiPolar-i Ø58/28mm
• 05056139234484: Corin BiPolar-i Ø57/28mm
• 05056139234477: Corin BiPolar-i Ø56/28mm
• 05056139234460: Corin BiPolar-i Ø55/28mm
• 05056139234453: Corin BiPolar-i Ø54/28mm
• 05056139234446: Corin BiPolar-i Ø53/28mm
• 05056139234439: Corin BiPolar-i Ø52/28mm
• 05056139234422: Corin BiPolar-i Ø51/28mm
• 05056139234415: Corin BiPolar-i Ø50/28mm
• 05056139234408: Corin BiPolar-i Ø49/28mm
• 05056139234392: Corin BiPolar-i Ø48/28mm
• 05056139234385: Corin BiPolar-i Ø47/28mm
• 05056139234378: Corin BiPolar-i Ø46/28mm
• 05056139234361: Corin BiPolar-i Ø44/28mm
• 05056139234354: Corin BiPolar-i Ø43/22mm
• 05056139234330: Corin BiPolar-i Ø39/22mm
• 05056139234323: Corin BiPolar-i Ø38/22mm
• 05056139234286: BiPolar-i Instrument Tray
• 05055343860786: Femoral Head Gauge
• 05056139234309: Press Tray