Endo-Boot
The Endo-Boot tip protector is used as a protective cover for the tip of the endoscope or other surgical instruments during storage and transport.
1manufacturer
4catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Smartdata Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 11 |
Record
| Listed by | Us Endoscopy, United States |
|---|---|
| FDA product code | OCU |
| Device type | Endoscopic Storage Cover |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Record published | 2016-09-17 |
| Record revised | 2020-03-31 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 15 to 25 °C |
| Packaging | Box of 2, case of 2 |
| Distribution end date | 2020-03-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 00711621 | 25 | In distribution | |
| 00711622 | 25 | In distribution | |
| 00711622 | 25 | Withdrawn | |
| 00711621 | 25 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| andorate® Universal Endoscope Tip Guard | GA Health Company Limited | 2 |
| ProArmor | Us Endoscopy | 2 |
| Protech XL | Meditech Endoscopy Ltd | 1 |
| Protech L | Meditech Endoscopy Ltd | 1 |
| Protech S | Meditech Endoscopy Ltd | 1 |
| Scope Guard | Gyrus Acmi, Inc. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.