HAART 200-21US
GUDID 10857160006246
Aortic Annuloplasty Device
BIOSTABLE ENGINEERING & SCIENCE
Aortic annuloplasty ring| Primary Device ID | 10857160006246 |
| NIH Device Record Key | d2d3f268-a50e-4edb-9f65-60fcb19b18a3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HAART |
| Version Model Number | 200-21US |
| Catalog Number | 200-21US |
| 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 | 10857160006246 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K171431
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 | 2017-09-27 |
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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