Guardus
- Primary DI
- 10816765012021
- Brand
- Guardus
- Company
- US Endoscopy
- Model
- SI711146
- Catalog number
- SI711146
- Device description
- The disposable overtube is used in conjunction with a flexible endoscope for foreign body or tissue retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations.
- Published
- 2016-09-17
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
Contact Domains#
xx.xxProduct Codes#
| Code | Name |
|---|---|
| FED | endoscopic access overtube, gastroenterology-urology |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Gastroenterology, Urology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K040836 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10816765012021 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10816765012021 | 10816765012021 |
GMDN Terms#
| Term | Definition |
|---|---|
| Endoscopic overtube, single-use | A tubular device intended to be used in combination with a compatible flexible endoscope to aid in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures (e.g., upper and/or lower gastrointestinal (GI) tract endoscopy). It is a non-steerable, typically single lumen tube constructed of plastic; some types may be "shape locked" into a desired configuration or form to assist in the repeated advancement and withdrawal of the endoscope (e.g., for the removal of multiple polyps and/or foreign bodies). This is a single-use device. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Length | 25 | Centimeter |
| Lumen/Inner Diameter | 17 | Millimeter |
| Outer Diameter | 19.5 | Millimeter |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 15 Degrees Celsius | 25 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(800)548-4873 | xx@xx.xx |
Regulatory Flags#
- DUNS number
- 627879687
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- No natural rubber latex
- true
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| 10724995184022 | Endo-Boot | 00711622 | 00711622 | 2020-04-01 |
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| 00724995190644 | ProArmor | 00711624 | 00711624 | 2020-07-16 |
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| 00724995180386 | NA | 710304 | 710304 | 2020-04-02 |
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| 00724995180416 | NA | 710425 | 710425 | 2020-04-02 |
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| 00724995180430 | NA | 710602 | 710602 | 2020-04-02 |
| 00724995180447 | NA | 710603 | 710603 | 2020-04-02 |
| 00724995180454 | NA | 710604 | 710604 | 2020-04-02 |
| 00724995180522 | Torrent | 00711579 | 00711579 | 2020-04-01 |
| 00724995180768 | Ultramatrix | USBOL | USBOL | 2020-04-02 |
| 00724995180775 | Ultramatrix | USBOR | USBOR | 2020-04-02 |
| 00724995180782 | iSnare | 00711084 | 00711084 | 2020-03-19 |
| 00724995180843 | Articulator | 00711804 | 00711804 | 2020-04-01 |
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