| Primary Device ID | 00846832022250 |
| NIH Device Record Key | cee87fe9-3b05-40aa-b10e-6bcfc53fab24 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tornier Simpliciti |
| Version Model Number | 9722928 |
| Catalog Number | 9722928 |
| Company DUNS | 968990812 |
| Company Name | TORNIER, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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 |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846832022250 [Primary] |
| FZX | Guide, surgical, instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846832022250]
Moist Heat or Steam Sterilization
[00846832022250]
Moist Heat or Steam Sterilization
[00846832022250]
Moist Heat or Steam Sterilization
[00846832022250]
Moist Heat or Steam Sterilization
[00846832022250]
Moist Heat or Steam Sterilization
[00846832022250]
Moist Heat or Steam Sterilization
[00846832022250]
Moist Heat or Steam Sterilization
[00846832022250]
Moist Heat or Steam Sterilization
[00846832022250]
Moist Heat or Steam Sterilization
[00846832022250]
Moist Heat or Steam Sterilization
[00846832022250]
Moist Heat or Steam Sterilization
[00846832022250]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-17 |
| Device Publish Date | 2022-08-09 |
| 00846832072842 | NUCLEUS TEMPLATES |
| 00846832072835 | HUMERAL HEAD TEMPLATE |
| 00846832024995 | HUMERAL HEAD TRIAL |
| 00846832024988 | HUMERAL HEAD TRIAL |
| 00846832024971 | HUMERAL HEAD TRIAL |
| 00846832024964 | HUMERAL HEAD TRIAL |
| 00846832024957 | HUMERAL HEAD TRIAL |
| 00846832024940 | HUMERAL HEAD TRIAL |
| 00846832024933 | HUMERAL HEAD TRIAL |
| 00846832024926 | HUMERAL HEAD TRIAL |
| 00846832024919 | HUMERAL HEAD TRIAL |
| 00846832024902 | Fin Blazer Trial |
| 00846832024896 | Fin Blazer Trial |
| 00846832024889 | Fin Blazer Trial |
| 00846832024872 | SURFACE PLANER |
| 00846832024865 | SURFACE PLANER |
| 00846832024858 | SURFACE PLANER |
| 00846832024841 | SURFACE PLANER |
| 00846832024834 | Sizer Disk |
| 00846832024827 | Sizer Disk |
| 00846832022267 | Cut Ring |
| 00846832022250 | Cut Ring |
| 00846832022243 | Cut Ring |
| 00846832022236 | Cut Ring |
| 00846832022229 | Inclination Guide |
| 00846832022212 | Humeral Head Distractor |
| 00846832022205 | Humeral Head Impactor Tip |
| 00846832022199 | Nucleus Impactor |
| 00846832022182 | Cut Protector Handle |
| 00846832022175 | Humeral Cut Protector |
| 00846832022168 | Humeral Cut Protector |
| 00846832022151 | Humeral Cut Protector |
| 00846832022144 | Grasper |
| 00846832022137 | Blazer/Head Impactor |
| 00846832022120 | CORE DRILL |
| 00846832022113 | PIN DRIVER |
| 00846832022106 | Self-Leveling Sizer Handle |
| 00846832022090 | Sizer Disk |
| 00846832017348 | GUIDE PIN |
| 00846832016013 | SLOTTED MALLET |
| 00846832016006 | THREADED EXTRACTOR |
| 00846832015993 | CORE EXTRACTOR |
| 00846832015986 | OSTEOTOME |
| 00846832015603 | CUT RING |
| 00846832023813 | Trial Head Case Lid |
| 00846832023806 | Trial Head Case Base |
| 00846832015962 | Revision Case Base |
| 00846832015948 | Trial Head Case Lid |
| 00846832015931 | Trial Head Case Base |