| Primary Device ID | M84946501 |
| NIH Device Record Key | ba2259d1-2e4f-453a-a253-5a21bb095497 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hobbs Medical Scope Introducer |
| Version Model Number | 4650 |
| Catalog Number | 4650 |
| Company DUNS | 076769355 |
| Company Name | HOBBS MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Labeled No Natural Rubber Latex | false |
| 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 | |
| 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 | |
| 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 | |
| Phone | 8606845875 |
| customerservice@hobbsmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M84946500 [Primary] |
| HIBCC | M84946501 [Package] Contains: M84946500 Package: Box [5 Units] In Commercial Distribution |
| FGY | Cannula, Injection |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-07-25 |
| Device Publish Date | 2022-06-14 |
| M84931020 - Flex-Ez Over the Wire Balloon Dilator | 2024-12-23 A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically dilate gastrointestinal strictur |
| M84931040 - Flex-Ez Over the Wire Balloon Dilator | 2024-12-23 A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically dilate gastrointestinal strictur |
| M84931060 - Flex-Ez Over the Wire Balloon Dilator | 2024-12-23 A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically dilate gastrointestinal strictur |
| M84931520 - Flex-Ez Over the Wire Balloon Dilator | 2024-12-23 A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically dilate gastrointestinal strictur |
| M84931560 - Flex-Ez Over the Wire Balloon Dilator | 2024-12-23 A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically dilate gastrointestinal strictur |
| M84931580 - Flex-Ez Over the Wire Balloon Dilator | 2024-12-23 A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically dilate gastrointestinal strictur |
| M84931800 - Biliary Over the Wire Balloon Dilator | 2024-12-23 A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically dilate gastrointestinal strictur |
| M84931820 - Biliary Over the Wire Balloon Dilator | 2024-12-23 A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically dilate gastrointestinal strictur |