POLARCUP E0015546-12

GUDID 00885556701287

TANDEM STYLE POLAR CUP TRIAL LINER 65/28

Smith & Nephew, Inc.

Acetabulum prosthesis trial, reusable Acetabulum prosthesis trial, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable

• Primary Device ID: 00885556701287
• NIH Device Record Key: 0d6a0073-181e-4f40-8c36-a655dd07c203
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POLARCUP
• Version Model Number: E0015546-12
• Catalog Number: E0015546-12
• Company DUNS: 109903521
• 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: 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

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
• 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
• 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
• 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	00885556701287 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123598

FDA Product Code

• JDG: Prosthesis, hip, femoral component, cemented, metal

Sterilization

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

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

[00885556701287]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2017-09-18

On-Brand Devices [POLARCUP]

• 00885556701294: TANDEM STYLE POLAR CUP TRIAL LINER 67/28
• 00885556701287: TANDEM STYLE POLAR CUP TRIAL LINER 65/28
• 00885556701270: TANDEM STYLE POLAR CUP TRIAL LINER 63/28
• 00885556701263: TANDEM STYLE POLAR CUP TRIAL LINER 61/28
• 00885556701256: TANDEM STYLE POLAR CUP TRIAL LINER 59/28
• 00885556701249: TANDEM STYLE POLAR CUP TRIAL LINER 57/28
• 00885556701232: TANDEM STYLE POLAR CUP TRIAL LINER 55/28
• 00885556701225: TANDEM STYLE POLAR CUP TRIAL LINER 53/28
• 00885556701218: TANDEM STYLE POLAR CUP TRIAL LINER 51/28
• 00885556701201: TANDEM STYLE POLAR CUP TRIAL LINER 49/28
• 00885556701195: TANDEM STYLE POLAR CUP TRIAL LINER 47/28
• 00885556701188: TANDEM STYLE POLAR CUP TRIAL LINER 45/28
• 00885556701171: TANDEM STYLE POLAR CUP TRIAL LINER 43/28
• 07611996118988: BASIC CASE II POLARCUP 10
• 07611996118971: BASIC CASE I POLARCUP 10
• 07611996118964: CASE ACCESSORIES POLARCUP 10
• 07611996118957: CASE NAV POLARCUP 10
• 07611996118391: POLARCUP SHELL TI-PLASMA/HA 67 NON-CEM
• 07611996118384: POLARCUP SHELL TI-PLASMA/HA 65 NON-CEM
• 07611996118377: POLARCUP SHELL TI-PLASMA/HA 63 NON-CEM
• 07611996118360: POLARCUP SHELL TI-PLASMA/HA 61 NON-CEM
• 07611996118353: POLARCUP SHELL TI-PLASMA/HA 59 NON-CEM
• 07611996118346: POLARCUP SHELL TI-PLASMA/HA 57 NON-CEM
• 07611996118339: POLARCUP SHELL TI-PLASMA/HA 55 NON-CEM
• 07611996118322: POLARCUP SHELL TI-PLASMA/HA 53 NON-CEM
• 07611996118315: POLARCUP SHELL TI-PLASMA/HA 51 NON-CEM
• 07611996118308: POLARCUP SHELL TI-PLASMA/HA 49 NON-CEM
• 07611996118292: POLARCUP SHELL TI-PLASMA/HA 47 NON-CEM
• 07611996118285: POLARCUP SHELL TI-PLASMA/HA 45 NON-CEM
• 07611996118278: POLARCUP SHELL TI-PLASMA/HA 43 NON-CEM
• 07611996118094: POLARCUP SHELL TI-PLASMA 67 NON-CEM
• 07611996118070: POLARCUP SHELL TI-PLASMA 63 NON-CEM
• 07611996118063: POLARCUP SHELL TI-PLASMA 61 NON-CEM
• 07611996118056: POLARCUP SHELL TI-PLASMA 59 NON-CEM
• 07611996118049: POLARCUP SHELL TI-PLASMA 57 NON-CEM
• 07611996118032: POLARCUP SHELL TI-PLASMA 55 NON-CEM
• 07611996117981: POLARCUP SHELL TI-PLASMA 45 NON-CEM
• 07611996117974: POLARCUP SHELL TI-PLASMA 43 NON-CEM
• 07611996116885: POLARCUP TRIAL INSERT SLOTTED 28/67
• 07611996116878: POLARCUP TRIAL INSERT SLOTTED 28/65
• 07611996116861: POLARCUP TRIAL INSERT SLOTTED 28/63
• 07611996116854: POLARCUP TRIAL INSERT SLOTTED 28/61
• 07611996116847: POLARCUP TRIAL INSERT SLOTTED 28/59
• 07611996116830: POLARCUP TRIAL INSERT SLOTTED 28/57
• 07611996116823: POLARCUP TRIAL INSERT SLOTTED 28/55
• 07611996116816: POLARCUP TRIAL INSERT SLOTTED 28/53
• 07611996116809: POLARCUP TRIAL INSERT SLOTTED 28/51
• 07611996116793: POLARCUP TRIAL INSERT SLOTTED 28/49
• 07611996116786: POLARCUP TRIAL INSERT SLOTTED 28/47
• 07611996116779: POLARCUP TRIAL INSERT SLOTTED 22/67