Amplatzer™ Amulet™ 9-ACP2-010-031
GUDID 00811806013510
Left Atrial Appendage Occluder
ST. JUDE MEDICAL, INC.
Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder| Primary Device ID | 00811806013510 |
| NIH Device Record Key | 7b782246-d246-4a78-8f3a-1d461d85a9d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Amplatzer™ Amulet™ |
| Version Model Number | 9-ACP2-010-031 |
| Catalog Number | 9-ACP2-010-031 |
| Company DUNS | 149818952 |
| Company Name | ST. JUDE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
Device Dimensions
| Outer Diameter | 31 Millimeter |
| Outer Diameter | 31 Millimeter |
| Outer Diameter | 31 Millimeter |
| Outer Diameter | 31 Millimeter |
| Outer Diameter | 31 Millimeter |
| Outer Diameter | 31 Millimeter |
| Outer Diameter | 31 Millimeter |
| Outer Diameter | 31 Millimeter |
| Outer Diameter | 31 Millimeter |
| Outer Diameter | 31 Millimeter |
| Outer Diameter | 31 Millimeter |
| Outer Diameter | 31 Millimeter |
| Outer Diameter | 31 Millimeter |
| Outer Diameter | 31 Millimeter |
| Outer Diameter | 31 Millimeter |
| Outer Diameter | 31 Millimeter |
| Outer Diameter | 31 Millimeter |
| Outer Diameter | 31 Millimeter |
| Outer Diameter | 31 Millimeter |
| Outer Diameter | 31 Millimeter |
| Outer Diameter | 31 Millimeter |
| Outer Diameter | 31 Millimeter |
| Outer Diameter | 31 Millimeter |
| Outer Diameter | 31 Millimeter |
| Outer Diameter | 31 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811806013510 [Primary] |
FDA Product Code
| NGV | System, appendage closure, left atrial |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-24 |
| Device Publish Date | 2021-08-16 |
On-Brand Devices [Amplatzer™ Amulet™]
| 00811806013527 | Left Atrial Appendage Occluder |
| 00811806013510 | Left Atrial Appendage Occluder |
| 00811806013503 | Left Atrial Appendage Occluder |
| 00811806013497 | Left Atrial Appendage Occluder |
| 00811806013480 | Left Atrial Appendage Occluder |
| 00811806013473 | Left Atrial Appendage Occluder |
| 00811806013466 | Left Atrial Appendage Occluder |
| 00811806013459 | Left Atrial Appendage Occluder |
Trademark Results [Amplatzer]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AMPLATZER 75263094 2144604 Live/Registered |
ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC. 1997-03-24 |
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