Guardus
- Primary DI
- 10816765011239
- Brand
- Guardus
- Company
- US Endoscopy
- Model
- 00711149
- Catalog number
- 00711149
- 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
- OTC
- false
- Sterile
- false
- 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 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10816765011239 | Package | GS1 | 3 | Not in Commercial Distribution |
| 00816765011232 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10816765011239 | 10816765011239 | ||
| 00816765011232 | 00816765011232 | 816765011232 | 0816765011232 |
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 | 50 | Centimeter |
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
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00724995182557 | Exacto | 00711094 | 00711094 | 2021-03-31 |
| 00724995182564 | Exacto | 00711095 | 00711095 | 2021-03-31 |
| 00724995182618 | Exacto | 00711115 | 00711115 | 2021-03-31 |
| 00724995243746 | Exacto Mundo | 00711114 | 00711114 | 2025-01-31 |
| 00724995180959 | VIA | 00717001 | 00717001 | 2020-01-31 |
| 00724995181116 | VIA | 00717019 | 00717019 | 2020-01-30 |
| 00724995181420 | VIA | 00717051 | 00717051 | 2020-01-30 |
| 00724995181451 | VIA | 00717054 | 00717054 | 2020-01-30 |
| 00724995181505 | VIA | 00717059 | 00717059 | 2020-01-30 |
| 00724995181659 | VIA | 00717076 | 00717076 | 2020-01-30 |
| 00724995182984 | VIA | 00717141 | 00717141 | 2020-01-30 |
| 00724995183073 | VIA | 00717155 | 00717155 | 2020-07-16 |
| 00724995183141 | VIA | 00717167 | 00717167 | 2020-01-30 |
| 00724995183257 | VIA | 00717182 | 00717182 | 2020-01-30 |
| 00724995190699 | VIA | 00717223 | 00717223 | 2020-01-30 |
| 00724995190736 | VIA | 00717234 | 00717234 | 2020-01-30 |
| 00724995193966 | VIA | 00717269 | 00717269 | 2020-02-04 |
| 00724995194123 | VIA | 00717229 | 00717229 | 2020-02-07 |
| 00724995194987 | VIA | 00717310 | 00717310 | 2020-03-23 |
| 00724995203412 | VIA | 00717337 | 00717337 | 2020-10-20 |
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| 06973356551769 | Trious | Shenzhen Trious Medical Technology Co., Ltd | FED | 2026-06-23 |
| 06973356551776 | Trious | Shenzhen Trious Medical Technology Co., Ltd | FED | 2026-06-23 |
| 06973356551783 | Trious | Shenzhen Trious Medical Technology Co., Ltd | FED | 2026-06-23 |
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| 06936345104544 | Disposable Ureteral Guide Sheath | Dongguan ZSR Biomedical Technology Company Limited | FED | 2026-05-27 |
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