Affiniti™ EH²
GUDID 00846832002221
TORNIER, INC.
Coated shoulder humeral stem prosthesis| Primary Device ID | 00846832002221 |
| NIH Device Record Key | 6b86f8e6-ae33-4902-a5e1-51113251925e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Affiniti™ EH² |
| Version Model Number | 0020082 |
| 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 | 00846832002221 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K073331
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™ EH²]
| 00846832002252 | 0020085 |
| 00846832002245 | 0020084 |
| 00846832002238 | 0020083 |
| 00846832002221 | 0020082 |
| 00846832002214 | 0020081 |
| 00846832002207 | 0020080 |
| 00846832002191 | 0020079 |
| 00846832002184 | 0020078 |
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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