Primary Device ID | 00846832015986 |
NIH Device Record Key | 3954b3b1-97b6-48bd-a59a-cdfaef62aba2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Tornier Simpliciti |
Version Model Number | 9722935 |
Catalog Number | 9722935 |
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 | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00846832015986 [Primary] |
HWM | OSTEOTOME |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
Moist Heat or Steam Sterilization
[00846832015986]
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 |