Identity
- Trade Name
- Guardus FDA UDI
- Generic Name
- Endoscopic overtube, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- SI711146 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- SI711146 FDA UDI
- Primary DI / UDI-DI
- 00724995184483 FDA UDI
- FDA Product Code
- FED FDA UDI
- GMDN Term
- Endoscopic overtube, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 19.5 Millimeter FDA UDILength — 25 Centimeter FDA UDILumen/Inner Diameter — 17 Millimeter FDA UDI
Category: Endoscopic overtube, single-use
Guardus by US Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic overtube, single-use.
- Pathfinder® — Neptune Medical · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- endomina platform — Endo Tools Therapeutics · Class II
- Pathfinder — Neptune Medical · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- Flexible Overtube — SB-KAWASUMI LABORATORIES, INC. · Class II
- Ancora — ASPERO MEDICAL, INC. · Class II
- Pathfinder® Endoscope Overtube with Balloon — Neptune Medical · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- US Endoscopy
Sources (1)
- FDA UDI 0b711618-adf0-4eb8-89f4-c9aa655b0619 37 fields · synced May 31, 2026