POLARCUP E0015546-2
GUDID 00885556701188
TANDEM STYLE POLAR CUP TRIAL LINER 45/28
Smith & Nephew, Inc.
Acetabulum prosthesis trial, reusable| Primary Device ID | 00885556701188 |
| NIH Device Record Key | f7eba9b3-c18a-48e4-8223-b3f15591833c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | POLARCUP |
| Version Model Number | E0015546-2 |
| Catalog Number | E0015546-2 |
| 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 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556701188 [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 |
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
Moist Heat or Steam Sterilization
[00885556701188]
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 |
Trademark Results [POLARCUP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POLARCUP 77391011 3894254 Live/Registered |
Smith & Nephew Orthopaedics AG 2008-02-07 |
 POLARCUP 74674982 not registered Dead/Abandoned |
Huhtamaki Finance B.V. 1995-05-17 |
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