| Primary Device ID | 10857160006338 |
| NIH Device Record Key | 7ce50625-c4d2-4ee5-b0f2-0c7d3564fe4a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HAART Polyester Pledget 6-Pack |
| Version Model Number | 100-06US |
| Catalog Number | 100-06US |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10857160006338 [Primary] |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2019-10-31 |
| 10857160006239 - HAART | 2021-02-05 Aortic Annuloplasty Ring |
| 10857160006246 - HAART | 2021-02-05 Aortic Annuloplasty Device |
| 10857160006253 - HAART | 2021-02-05 Aortic Annuloplasty Device |
| 10857160006260 - HAART | 2021-02-05 Aortic Annuloplasty Device |
| 10857160006277 - HAART | 2021-02-05 Aortic Annuloplasty Ring |
| 10857160006284 - HAART | 2021-02-05 Aortic Annuloplasty Device |
| 10857160006291 - HAART | 2021-02-05 Aortic Annuloplasty Ring |
| 10857160006307 - HAART | 2021-02-05 Aortic Annuloplasty Ring |