Corin BiPolar-i S208.002

GUDID 05055343860786

Femoral Head Gauge

CORIN LTD

Surgical implant template, reusable

• Primary Device ID: 05055343860786
• NIH Device Record Key: 8af22213-f078-47b8-a40b-4f6f47fb5650
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Corin BiPolar-i
• Version Model Number: S208.002
• Catalog Number: S208.002
• 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: false
• Lot Batch: true
• 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	05055343860786 [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: false

[05055343860786]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-18
• Device Publish Date: 2019-09-10

On-Brand Devices [Corin BiPolar-i]

• 05056139234576: Corin BiPolar-i Ø45/28mm
• 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