| Primary Device ID | M84931800 |
| NIH Device Record Key | e5fe5392-df59-418a-a11c-c23fe1f8679e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biliary Over the Wire Balloon Dilator |
| Version Model Number | 3180 |
| Catalog Number | 3180 |
| Company DUNS | 076769355 |
| Company Name | HOBBS MEDICAL, 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 8606845875 |
| customerservice@hobbsmedical.com | |
| Phone | 8606845875 |
| customerservice@hobbsmedical.com | |
| Phone | 8606845875 |
| customerservice@hobbsmedical.com | |
| Phone | 8606845875 |
| customerservice@hobbsmedical.com | |
| Phone | 8606845875 |
| customerservice@hobbsmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M84931800 [Primary] |
| KNQ | Dilator, Esophageal |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-12-23 |
| Device Publish Date | 2016-09-21 |
| M84931840 | A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically |
| M84931820 | A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically |
| M84931800 | A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically |