| Primary Device ID | 04961333240258 |
| NIH Device Record Key | 038f34db-728e-438e-8d57-d5a834ab9c6c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FIBER BRONCHOSCOPE |
| Version Model Number | FB-18RBS |
| Company DUNS | 083211284 |
| Company Name | PENTAX OF AMERICA, 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 | false |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04961333240258 [Primary] |
| EOQ | Bronchoscope (Flexible Or Rigid) |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04961333240258]
Ethylene Oxide;High-level Disinfectant
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-04-12 |
| Device Publish Date | 2018-03-12 |
| 04961333240258 | FIBEROPTICBRONCHOSCOPE 2.6C 5.9TP RO PLS (USED) |
| 04961333240241 | FIBEROPTICBRONCHOSCOPE 2.0C 4.8TP RO PLS (USED) |
| 04961333232697 | FIBEROPTIC BRONCHOSCOPE 1.2C 2.7TP 600L (REFURBISHED) |
| 04961333232680 | FIBEROPTIC BRONCHOSCOPE 2.8C 5.9TP 600L (REFURBISHED) |
| 04961333232673 | FIBER BRONCHOSCOPE TD5.9,CD2.8 (REFURBISHED) |
| 04961333232666 | FIBEROPTIC BRONCHOSCOPE 2.2C 4.9TP 600L (REFURBISHED) |
| 04961333232659 | FIBER BRONCHOSCOPE (REFURBISHED) |