Affiniti™
GUDID 00846832002078
TORNIER, INC.
Coated shoulder humeral stem prosthesis| Primary Device ID | 00846832002078 |
| NIH Device Record Key | c0ca7a98-bafb-4d77-a0ed-ba531663febb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Affiniti™ |
| Version Model Number | 0020053 |
| 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 | true |
| Serial Number | false |
| 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
Device Dimensions
| Outer Diameter | 52 Millimeter |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 52 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846832002078 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K060988
FDA Product Code
| HSD | PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED |
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 [Affiniti™]
| 00846832002115 | 0020058 |
| 00846832002108 | 0020057 |
| 00846832002092 | 0020056 |
| 00846832002085 | 0020054 |
| 00846832002078 | 0020053 |
| 00846832002061 | 0020052 |
| 00846832002054 | 0020050 |
| 00846832002047 | 0020049 |
| 00846832002030 | 0020048 |
| 00846832002023 | 0020046 |
| 00846832002016 | 0020045 |
| 00846832002009 | 0020044 |
| 00846832001996 | 0020042 |
| 00846832001989 | 0020041 |
| 00846832001972 | 0020040 |
| 00846832001965 | 0020038 |
| 00846832001958 | 0020037 |
| 00846832001941 | 0020034 |
| 00846832001934 | 0020033 |
| 00846832001927 | 0020030 |
| 00846832001910 | 0020029 |
| 00846832001903 | 0020026 |
| 00846832001897 | 0020025 |
| 00846832001880 | 0020022 |
| 00846832001873 | 0020021 |
| 00846832001866 | 0020018 |
| 00846832001859 | 0020016 |
| 00846832001842 | 0020015 |
| 00846832001835 | 0020014 |
| 00846832001828 | 0020013 |
| 00846832001811 | 0020012 |
| 00846832001804 | 0020011 |
| 00846832001798 | 0020010 |
| 00846832001781 | 0020009 |
| 00846832001774 | 0020008 |
| 00846832001767 | 0020006 |
Trademark Results [Affiniti]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AFFINITI 97477382 not registered Live/Pending |
SuperLayer Labs Management, LLC 2022-06-27 |
 AFFINITI 97044570 not registered Live/Pending |
Halyard MD Opco, LLC 2021-09-24 |
 AFFINITI 85514563 not registered Dead/Abandoned |
KATZ, Steven 2012-01-11 |
AFFINITI 85514563 not registered Dead/Abandoned |
KATZ, Cecile 2012-01-11 |
 AFFINITI 81016986 1016986 Dead/Cancelled |
Wilwood, Inc. 0000-00-00 |
 AFFINITI 79143766 4590914 Live/Registered |
Koninklijke Philips nv 2014-01-22 |
 AFFINITI 77873733 3938734 Live/Registered |
Tornier, Inc. 2009-11-16 |
 AFFINITI 77813762 not registered Dead/Abandoned |
Terrazzo & Marble Supply Co. of IL 2009-08-27 |
 AFFINITI 77593592 not registered Dead/Abandoned |
DATALOGIX, INC. 2008-10-15 |
 AFFINITI 77100548 not registered Dead/Abandoned |
Farberware Licensing Company, LLC 2007-02-06 |
 AFFINITI 76154175 not registered Dead/Abandoned |
Affiniti, Inc. 2000-10-26 |
 AFFINITI 74597990 1928253 Dead/Cancelled |
CIGNA Corporation 1994-11-14 |
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