Identity
- Trade Name
- Entrada FDA UDI
- Generic Name
- Endoscopic overtube, single-use FDA UDI
- Device Name
- Entrada Colonic Overtube FDA UDI
- Model / Reference
- 00711145 FDA UDI
- Description
- Entrada Colonic Overtube FDA UDI
Identifiers
- Catalog Number
- 00711145 FDA UDI
- Primary DI / UDI-DI
- 00816765011195 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
- Not 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
Dimensions & Sizes
- Size
- Outer Diameter — 19.8 Millimeter FDA UDILength — 40 Centimeter FDA UDILumen/Inner Diameter — 17 Millimeter FDA UDI
Entrada by US Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 dceb1673-7b20-4821-8e91-92a5bc788bac 38 fields · synced May 30, 2026