| Primary Device ID | 00850031897083 |
| NIH Device Record Key | 3777642a-d202-41c7-b1e7-4a3297eb9375 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Single-Use Gastroscope 3.5/2.0 85cm 5-pack |
| Version Model Number | LE |
| Catalog Number | 1025 |
| Company DUNS | 117077970 |
| Company Name | Evoendo, 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 00850031897076 - Single-Use Gastroscope 3.5/2.0 85cm | 2024-09-09 The EvoEndo Endoscope is a sterile, single use gastroscope intended to perform oral or transnasal diagnostic endoscopy in adult |
| 00850031897083 - Single-Use Gastroscope 3.5/2.0 85cm 5-pack | 2024-09-09The EvoEndo Endoscope is a sterile, single use gastroscope intended to perform oral or transnasal diagnostic endoscopy in adult and pediatric patients. The EvoEndo Endoscope is ethylene oxide (EO) sterilized and is comprised of:
- Handle
- Umbilical Bundle that includes air, water, and suction lines, as well as the video connector
- Endoscope shaft with HD Camera |
| 00850031897083 - Single-Use Gastroscope 3.5/2.0 85cm 5-pack | 2024-09-09 The EvoEndo Endoscope is a sterile, single use gastroscope intended to perform oral or transnasal diagnostic endoscopy in adult |
| 00850031897090 - Single-Use Gastroscope 3.5/2.0 85cm DEMO | 2024-09-09 The EvoEndo Endoscope is a sterile, single use gastroscope intended to perform oral or transnasal diagnostic endoscopy in adult |
| 00850031897014 - EvoEndo Model LE Single-Use Gastroscope | 2022-03-07 The EvoEndo Endoscope is a sterile, single use gastroscope intended to perform oral or transnasal diagnostic endoscopy in adult |
| 00850031897021 - EvoEndo Controller | 2022-03-07 The Controller of the EvoEndo Endoscopy System translates the images or video captured by the camera at the distal end of the Ev |
| 00850031897038 - EvoEndo Model LE Single-Use Gastroscope | 2022-03-07 The EvoEndo Endoscope is a sterile, single use gastroscope intended to perform oral or transnasal diagnostic endoscopy in adult |