| Primary Device ID | 04961333232635 |
| NIH Device Record Key | 35ba7133-c451-40c0-a717-97bf10baa685 |
| Commercial Distribution Discontinuation | 2017-04-06 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | VIDEO SIGMOIDOSCOPE |
| Version Model Number | ES-3830K |
| 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 | false |
| Serial Number | true |
| 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 | 04961333232635 [Primary] |
| FAM | Sigmoidoscope And Accessories, Flexible/Rigid |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04961333232635]
Ethylene Oxide;High-level Disinfectant
[04961333232635]
Ethylene Oxide;High-level Disinfectant
[04961333232635]
Ethylene Oxide;High-level Disinfectant
[04961333232635]
Ethylene Oxide;High-level Disinfectant
[04961333232635]
Ethylene Oxide;High-level Disinfectant
[04961333232635]
Ethylene Oxide;High-level Disinfectant
[04961333232635]
Ethylene Oxide;High-level Disinfectant
[04961333232635]
Ethylene Oxide;High-level Disinfectant
[04961333232635]
Ethylene Oxide;High-level Disinfectant
[04961333232635]
Ethylene Oxide;High-level Disinfectant
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-04-06 |
| 04961333232642 | VIDEO SIGMOIDOSCOPE 4.2C 12.8T 700L FWJ (REFURBISHED) |
| 04961333232635 | VIDEO SIGMOIDOSCOPES (REFURBISHED) |