Simpliciti™
GUDID 00846832061372
TORNIER, INC.
Stem-fixed humeral head prosthesis| Primary Device ID | 00846832061372 |
| NIH Device Record Key | c679a734-2d4a-4875-a09b-8046b5825624 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Simpliciti™ |
| Version Model Number | 7122887 |
| Company DUNS | 968990812 |
| Company Name | TORNIER, 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(888)494-7950 |
| customerservice@tornier.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846832061372 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K143552
FDA Product Code
| PKC | Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-16 |
On-Brand Devices [Simpliciti™]
| 00846832061440 | DWG403 |
| 00846832061433 | DWG402 |
| 00846832061426 | DWG401 |
| 00846832061419 | 7122891 |
| 00846832061402 | 7122890 |
| 00846832061396 | 7122889 |
| 00846832061389 | 7122888 |
| 00846832061372 | 7122887 |
| 00846832061365 | 7122886 |
| 00846832061358 | 7122885 |
| 00846832061341 | 7122884 |
| 00846832061334 | 7122883 |
| 00846832061327 | 7122882 |
| 00846832061310 | 7122881 |
| 00846832061303 | 7122880 |
| 00846832061297 | 7122879 |
| 00846832061280 | 7122878 |
| 00846832061273 | 7122877 |
| 00846832004904 | 7122876 |
| 00846832004898 | 7122875 |
| 00846832004881 | 7122874 |
| 00846832004874 | 7122873 |
| 00846832004867 | 7122872 |
| 00846832004850 | 7122871 |
| 00846832004843 | 7122870 |
| 00846832004836 | 7122869 |
| 00846832004829 | 7122868 |
Trademark Results [Simpliciti]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIMPLICITI 78248717 not registered Dead/Abandoned |
Simpliciti, Inc. 2003-05-12 |
 SIMPLICITI 77933746 4436760 Live/Registered |
Tornier, Inc. 2010-02-11 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.