Identity
- Trade Name
- OverTube™ FDA UDI
- Generic Name
- Endoscopic overtube, single-use FDA UDI
- Device Name
- Endoscopic Access System FDA UDI
- Model / Reference
- M00505560 FDA UDI
- Description
- Endoscopic Access System FDA UDI
Identifiers
- Catalog Number
- M00505560 FDA UDI
- Primary DI / UDI-DI
- 00191506049379 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscopic overtube, single-use
OverTube™ by Boston Scientific — 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
- Guardus — US Endoscopy · Class II
- Guardus — US Endoscopy · 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
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 |
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Manufacturer
- Manufacturer
- Boston Scientific
Sources (1)
- FDA UDI 1ee06c39-3cb2-46d1-ac28-f426ee541e97 34 fields · synced Jun 6, 2026