Aequalis™ Humeral Nail
GUDID 00846832002276
TORNIER, INC.
Arthrodesis nail, sterile| Primary Device ID | 00846832002276 |
| NIH Device Record Key | 1bca632c-915a-4aec-9bbd-69d8a3b34e4e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aequalis™ Humeral Nail |
| Version Model Number | 0020600 |
| 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
| Length | 130 Millimeter |
| Length | 130 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 130 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 130 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 130 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 130 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 130 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 130 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 130 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 130 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 130 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 130 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 130 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 130 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 130 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 130 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 130 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 130 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 130 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 130 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 130 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 130 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 130 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846832002276 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K082754
FDA Product Code
| HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES |
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 | 2015-09-22 |
On-Brand Devices [Aequalis™ Humeral Nail]
| 00846832017287 | 7424532 |
| 00846832017270 | 7424530 |
| 00846832017263 | 7424528 |
| 00846832017256 | 7424526 |
| 00846832017249 | 7424524 |
| 00846832017232 | 7424522 |
| 00846832017225 | 7424520 |
| 00846832017218 | 7525064 |
| 00846832017201 | 7525048 |
| 00846832017195 | 7525036 |
| 00846832017188 | 7525032 |
| 00846832017171 | 7425056 |
| 00846832017164 | 7425052 |
| 00846832017157 | 7425048 |
| 00846832017140 | 7425044 |
| 00846832017133 | 7425040 |
| 00846832017126 | 7425036 |
| 00846832017119 | 7425032 |
| 00846832017102 | 7425028 |
| 00846832017096 | 7525060 |
| 00846832017089 | 7525056 |
| 00846832017072 | 7525052 |
| 00846832017065 | 7525044 |
| 00846832017058 | 7525040 |
| 00846832017041 | 7525028 |
| 00846832017034 | 7525024 |
| 00846832002276 | 0020600 |
| 00846832002269 | 0020500 |
Trademark Results [Aequalis]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AEQUALIS 87686345 5497682 Live/Registered |
Nutrition DNA Pty Ltd. 2017-11-15 |
 AEQUALIS 86159677 4927977 Live/Registered |
CCP2, LLC 2014-01-07 |
 AEQUALIS 85437537 not registered Dead/Abandoned |
M&H Management Limited 2011-10-03 |
 AEQUALIS 77730372 not registered Dead/Abandoned |
M&H Management Limited 2009-05-06 |
 AEQUALIS 74670341 2178808 Dead/Cancelled |
AEQUALIS FURNITURE, L.L.C. 1995-05-05 |
 AEQUALIS 74536909 2055775 Live/Registered |
TORNIER 1994-06-13 |
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