| Primary Device ID | 00864390000350 |
| NIH Device Record Key | 5a038a95-1462-4de6-9022-7ecf1b1d383d |
| Commercial Distribution Discontinuation | 2018-08-22 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Ultramatrix EUS Radial Balloon for Olympus & Pentax |
| Version Model Number | USB-OR |
| Catalog Number | USB-OR |
| Company DUNS | 780056289 |
| Company Name | N. M. BEALE COMPANY, 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 800-989-9558 |
| bealeco@verizon.net |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00864390000350 [Primary] |
| ITX | Transducer, Ultrasonic, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-03-18 |
| Device Publish Date | 2016-12-07 |
| 00864390000305 - Baleen Polyp Trap | 2020-03-18 |
| 00864390000312 - Clear Fit Scope Introducer | 2020-03-18 |
| 00864390000329 - EZ-MISTER Disposable Atomizer | 2020-03-18 |
| 00864390000336 - Ultramatrix EUS Linear Balloon for Olympus | 2020-03-18 |
| 00864390000343 - Ultramatrix EUS Linear Balloon for Pentax | 2020-03-18 |
| 00864390000350 - Ultramatrix EUS Radial Balloon for Olympus & Pentax | 2020-03-18 |
| 00864390000350 - Ultramatrix EUS Radial Balloon for Olympus & Pentax | 2020-03-18 |
| 00864390000367 - N-Doe Pillow | 2020-03-18 |