Identity
- Trade Name
- FUJIFILM FDA UDI
- Generic Name
- Endoscopic overtube, single-use FDA UDI
- Device Name
- This product is used in combination with a FUTIFILM Double Balloon Endoscope to assist the insertion of the Endoscope under the management of physicians in medical facilities. This product is used to assist with the movement of the scopes inside the upper or lower digestive tract. Do not use this product for any other purposes. This product is not intended for use for any neonates , infants or children FDA UDI
- Model / Reference
- TS-1314B FDA UDI
- Description
- This product is used in combination with a FUTIFILM Double Balloon Endoscope to assist the insertion of the Endoscope under the management of physicians in medical facilities. This product is used to assist with the movement of the scopes inside the upper or lower digestive tract. Do not use this product for any other purposes. This product is not intended for use for any neonates , infants or children FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410467260 FDA UDI
- FDA Product Code
- FDF FDA UDIFDA 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
Category: Endoscopic overtube, single-use
Fujifilm by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic overtube, single-use.
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- Guardus — US Endoscopy · Class II
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- Pathfinder — Neptune Medical · Class II
- Flexible Overtube — SB-KAWASUMI LABORATORIES, INC. · Class II
- Ancora — ASPERO MEDICAL, INC. · Class II
- Guardus — US Endoscopy · 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
- FUJIFILM Corporation
Sources (1)
- FDA UDI f755776f-b243-48c4-99c8-1c773680ae63 35 fields · synced May 30, 2026