HAART 300-21US
GUDID 10857160006284
Aortic Annuloplasty Device
BIOSTABLE ENGINEERING & SCIENCE
Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring Aortic annuloplasty ring| Primary Device ID | 10857160006284 |
| NIH Device Record Key | e1a50e04-3cf0-4a64-96fb-9491d242cfbd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HAART |
| Version Model Number | 300-21US |
| Catalog Number | 300-21US |
| Company DUNS | 012321281 |
| Company Name | BIOSTABLE ENGINEERING & SCIENCE |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10857160006284 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163608
FDA Product Code
| PST | Aortic Annuloplasty Ring |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-02-05 |
| Device Publish Date | 2017-05-15 |
On-Brand Devices [HAART]
| 10857160006307 | Aortic Annuloplasty Ring |
| 10857160006291 | Aortic Annuloplasty Ring |
| 10857160006284 | Aortic Annuloplasty Device |
| 10857160006277 | Aortic Annuloplasty Ring |
| 10857160006260 | Aortic Annuloplasty Device |
| 10857160006253 | Aortic Annuloplasty Device |
| 10857160006246 | Aortic Annuloplasty Device |
| 10857160006239 | Aortic Annuloplasty Ring |
Trademark Results [HAART]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HAART 78172481 2819695 Dead/Cancelled |
Haart Limited 2002-10-09 |
 HAART 77679691 4257921 Live/Registered |
BioStable Science & Engineering, Inc. 2009-02-27 |
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