OPERA 71975954

GUDID 03596010244826

OPERA CUP RIGHT 22MM ID 43MM OD

Smith & Nephew, Inc.

Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis

• Primary Device ID: 03596010244826
• NIH Device Record Key: b368c036-8ec9-4e14-b912-69aec6d5ac2c
• Commercial Distribution Discontinuation: 2016-07-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: OPERA
• Version Model Number: 71975954
• Catalog Number: 71975954
• Company DUNS: 045483575
• Company Name: Smith & Nephew, Inc.
• 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

Customer Support Contacts

• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010244826 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991538

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-07
• Device Publish Date: 2015-09-28

On-Brand Devices [OPERA]

• 03596010409508: OPERA FLANGED CUP STERILZATION TRAY
• 03596010409553: OPERA FLANGED CUP TRIAL SHELL 53MM
• 03596010409546: OPERA FLANGED CUP TRIAL SHELL 50MM
• 03596010409539: OPERA FLANGED CUP TRIAL SHELL 47MM
• 03596010409522: OPERA FLANGED CUP TRIAL SHELL 43MM
• 03596010409515: OPERA FLANGED CUP TRIAL SHELL 40MM
• 03596010380357: OPERA CUP LEFT 26MM ID 53MM OD
• 03596010380241: OPERA CUP LEFT 26MM ID 50MM OD
• 03596010380234: OPERA CUP RIGHT 26MM ID 50MM OD
• 03596010380142: OPERA CUP LEFT 28MM ID 53MM OD
• 03596010380128: OPERA CUP LEFT 28MM ID 50MM OD
• 03596010380111: OPERA CUP RIGHT 28MM ID 50MM OD
• 03596010380104: OPERA CUP LEFT 28MM ID 47MM OD
• 03596010380098: OPERA CUP RIGHT 28MM ID 47MM OD
• 03596010380081: OPERA CUP LEFT 28MM ID 43MM OD
• 03596010380074: OPERA CUP RIGHT 28MM ID 43MM OD
• 03596010380067: OPERA CUP LEFT 22MM ID 47MM OD
• 03596010380050: OPERA CUP RIGHT 22MM ID 47MM OD
• 03596010244833: OPERA CUP LEFT 22MM ID 43MM OD
• 03596010244826: OPERA CUP RIGHT 22MM ID 43MM OD
• 03596010244819: OPERA CUP LEFT 22MM ID 40MM OD
• 03596010244802: OPERA CUP RIGHT 22MM ID 40MM OD