| Primary Device ID | M84941012 |
| NIH Device Record Key | 68326ab2-883f-433b-8ea7-43111006ff7e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hobbs Medical Saccomanno Cell Transport System |
| Version Model Number | 4101 |
| Catalog Number | 4101 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M84941010 [Primary] |
| HIBCC | M84941012 [Package] Contains: M84941010 Package: Box [10 Units] In Commercial Distribution |
| LDZ | Fixative, Alcohol Containing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-20 |
| Device Publish Date | 2023-06-12 |
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| M84933040 - Hobbs Achalasia Dilation Balloon | 2025-12-22 A long flexible tube with an inflatable balloon at its distal tip used to dilate gastrointestinal strictures of the lower esopha |
| M84933060 - Hobbs Achalasia Dilation Balloon | 2025-12-22 A long flexible tube with an inflatable balloon at its distal tip used to dilate gastrointestinal strictures of the lower esopha |
| M84934060 - Flex-Ez Guidewire | 2025-12-22 A PTFE coated metal wire with a flexible tip designed to position a catheter or similar interventional device (e.g., a stent or |
| M84934100 - Flex-Ez Guidewire | 2025-12-22 A PTFE coated metal wire with a flexible tip designed to position a catheter or similar interventional device (e.g., a stent or |
| M84934120 - Flex-Ez Guidewire | 2025-12-22 A PTFE coated metal wire with a flexible tip designed to position a catheter or similar interventional device (e.g., a stent or |
| M84937640 - Flex-Ez Stylet Wire Balloon Dilator | 2025-12-22 A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically dilate gastrointestinal strictur |
| M84950040 - Hobbs Medical Grasping Forceps | 2025-12-22 A flexible manual device intended to be used in combination with a compatible endoscope to grasp foreign bodies. It is construct |