Identity
- Trade Name
- Flexible Overtube FDA UDI
- Generic Name
- Endoscopic overtube, single-use FDA UDI
- Device Name
- Flexible Overtube provides an access for repeated insertion and withdrawal of an endoscope for tissue or foreign body retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations. Flexible Overtube consists of an overtube with a coiled stainless steel skelton, a detachable seal unit for an endoscope, and a detachable mouthpiece for a patient. The steel skelton of the overtube prevents the overtube from being bent and collapsed while keeping flexibility of the overtube. The detachable seal unit named “AD rubber unit” can be attached to the proximal end of the overtube to maintain insufflation and minimize leakage of air during endoscopic treatment. The overtube can be locked with the mouthpiece to maintain the proper placement of the overtube. FDA UDI
- Model / Reference
- MD-48719 FDA UDI
- Description
- Flexible Overtube provides an access for repeated insertion and withdrawal of an endoscope for tissue or foreign body retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations. Flexible Overtube consists of an overtube with a coiled stainless steel skelton, a detachable seal unit for an endoscope, and a detachable mouthpiece for a patient. The steel skelton of the overtube prevents the overtube from being bent and collapsed while keeping flexibility of the overtube. The detachable seal unit named “AD rubber unit” can be attached to the proximal end of the overtube to maintain insufflation and minimize leakage of air during endoscopic treatment. The overtube can be locked with the mouthpiece to maintain the proper placement of the overtube. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04545499070098 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
Yes
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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 205 Millimeter FDA UDIOuter Diameter — 19 Millimeter FDA UDI
Category: Endoscopic overtube, single-use
Flexible Overtube by Sb-Kawasumi Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Sb-Kawasumi Laboratories, Inc.
Sources (1)
- FDA UDI cc9e2b9a-a53e-4d78-92a7-72be66e976f0 34 fields · synced May 30, 2026