Aequalis™ Ascend™ PTC
GUDID 00846832060443
TORNIER, INC.
Coated shoulder humeral stem prosthesis| Primary Device ID | 00846832060443 |
| NIH Device Record Key | 854ce8a5-3187-455b-9cb3-99ceaa490fc1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aequalis™ Ascend™ PTC |
| Version Model Number | 7503301A |
| 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 | false |
| Serial Number | true |
| 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 | 66 Millimeter |
| Length | 66 Millimeter |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 125 degree |
| Length | 66 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846832060443 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K120794
FDA Product Code
| KWS | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED |
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 [Aequalis™ Ascend™ PTC]
| 00846832060702 | 7503309C |
| 00846832060696 | 7503309B |
| 00846832060689 | 7503309A |
| 00846832060672 | 7503308C |
| 00846832060665 | 7503308B |
| 00846832060658 | 7503308A |
| 00846832060641 | 7503307C |
| 00846832060634 | 7503307B |
| 00846832060627 | 7503307A |
| 00846832060610 | 7503306C |
| 00846832060603 | 7503306B |
| 00846832060597 | 7503306A |
| 00846832060580 | 7503305C |
| 00846832060573 | 7503305B |
| 00846832060566 | 7503305A |
| 00846832060559 | 7503304C |
| 00846832060542 | 7503304B |
| 00846832060535 | 7503304A |
| 00846832060528 | 7503303C |
| 00846832060511 | 7503303B |
| 00846832060504 | 7503303A |
| 00846832060498 | 7503302C |
| 00846832060481 | 7503302B |
| 00846832060474 | 7503302A |
| 00846832060467 | 7503301C |
| 00846832060450 | 7503301B |
| 00846832060443 | 7503301A |
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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