Cenator Total Hip System 116.026

GUDID 05055196912885

MOD HEAD SHORT NECK

CORIN LTD

Metallic femoral head prosthesis

• Primary Device ID: 05055196912885
• NIH Device Record Key: fabb702f-babf-4487-b469-466dc803bb16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cenator Total Hip System
• Version Model Number: 116.026
• Catalog Number: 116.026
• 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	05055196912885 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K925866

FDA Product Code

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

Sterilization

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

[05055196912885]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-06
• Device Publish Date: 2016-08-17

On-Brand Devices [Cenator Total Hip System]

• 05055196988750: CENATOR CUP 28MM ID
• 05055196968622: MOD HEAD LONG NECK
• 05055196957992: CENATOR CUP
• 05055196957985: CENATOR CUP
• 05055196957978: CENATOR CUP
• 05055196957954: CENATOR CUP
• 05055196957947: CENATOR CUP
• 05055196957770: DOUBLE TROCHANTER WI
• 05055196957756: CENATOR CUP FLANGED
• 05055196957749: CENATOR CUP FLANGED
• 05055196957732: CENATOR CUP FLANGED
• 05055196957725: CENATOR CUP 28MM ID
• 05055196957718: CENATOR CUP 28MM ID
• 05055196957701: CENATOR CUP 28MM ID
• 05055196957572: CENATOR STEM
• 05055196957565: CENATOR STEM
• 05055196957541: CENATOR STEM
• 05055196957534: CENATOR STEM
• 05055196957497: CENATOR STEM
• 05055196957480: CENATOR STEM
• 05055196957473: CENATOR STEM
• 05055196957466: CENATOR STEM
• 05055196957459: CENATOR STEM
• 05055196939981: CENATOR CUP
• 05055196939967: CENATOR CUP
• 05055196939943: CENATOR CUP
• 05055196939929: CENATOR CUP
• 05055196928817: MOD ENDO HEAD LONG N
• 05055196928800: MOD ENDO HEAD LONG N
• 05055196928794: MOD ENDO HEAD LONG N
• 05055196913400: MOD HEAD SHORT NECK
• 05055196913394: MOD HEAD STD NECK
• 05055196912892: MOD HEAD SHORT NECK
• 05055196912885: MOD HEAD SHORT NECK
• 05055196912878: MOD HEAD SHORT NECK
• 05055196912618: MOD HEAD STD NECK
• 05055196912601: MOD HEAD STD NECK
• 05055196912595: MOD HEAD STD NECK
• 05055196912335: MOD HEAD LONG NECK
• 05055196912328: MOD HEAD LONG NECK
• 05055196912311: MOD HEAD LONG NECK