OPERA 71976115

GUDID 03596010380050

OPERA CUP RIGHT 22MM ID 47MM OD

Smith & Nephew, Inc.

Polyethylene acetabulum prosthesis

• Primary Device ID: 03596010380050
• NIH Device Record Key: 50baa19a-e824-47f7-927c-2c413fcf93db
• Commercial Distribution Discontinuation: 2016-07-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: OPERA
• Version Model Number: 71976115
• Catalog Number: 71976115
• 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	03596010380050 [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