| Primary Device ID | 84953170463927 |
| NIH Device Record Key | 3430bc1d-25e9-4d13-9d5e-b41066e54bd1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BALLOON3 |
| Version Model Number | MAJ-249 |
| Catalog Number | N5369531 |
| Company DUNS | 711789789 |
| Company Name | OLYMPUS MEDICAL SYSTEMS CORP. |
| Device Count | 20 |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04953170463921 [Primary] |
| GS1 | 84953170463927 [Unit of Use] |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-05 |
| Device Publish Date | 2025-02-25 |
| 04953170360442 | MAJ-249 |
| 04953170360435 | MAJ-236 |
| 04953170360428 | MAJ-233 |
| 14953170058889 | MAJ-249 |
| 14953170058858 | MAJ-236 |
| 14953170058780 | MAJ-233 |
| 84953170463927 | MAJ-249 |
| 84953170463910 | MAJ-233 |