Identity
- Trade Name
- ENDO SMARTCAP FDA UDI
- Generic Name
- Endoscopic insufflation tubing set, single-use FDA UDI
- Device Name
- ENDO SMARTCAP Kit for FUJIFILM GI Endoscopes for CO2 Connection with ENDO STRATUS FDA UDI
- Model / Reference
- 4005097 FDA UDI
- Description
- ENDO SMARTCAP Kit for FUJIFILM GI Endoscopes for CO2 Connection with ENDO STRATUS FDA UDI
Identifiers
- Catalog Number
- 4005097 FDA UDI
- Primary DI / UDI-DI
- 50724995219265 FDA UDI
- FDA Product Code
- FAJ FDA UDI
- GMDN Term
- Endoscopic insufflation tubing set, 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
Yes
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 insufflation tubing set, single-use
Endo Smartcap by Medivators Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endoscopic insufflation tubing set, single-use.
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Cleared under the same submission
K093665 also covers:
- ENDO SMARTCAP — MEDIVATORS INC.
- ENDO SMARTCAP — MEDIVATORS INC.
- ENDO SMARTCAP — MEDIVATORS INC.
- ENDO SMARTCAP — MEDIVATORS INC.
- ENDO SMARTCAP — MEDIVATORS INC.
- ENDO SMARTCAP — MEDIVATORS INC.
- ENDO SMARTCAP — MEDIVATORS INC.
- ENDO SMARTCAP — MEDIVATORS INC.
- ENDO SMARTCAP — MEDIVATORS INC.
- ENDO SMARTCAP — MEDIVATORS INC.
- ENDO SMARTCAP — MEDIVATORS INC.
- ENDO SMARTCAP — MEDIVATORS INC.
K223040 also covers:
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
- Medivators Inc.
Sources (1)
- FDA UDI bf1bea35-8976-42cc-98fb-a38625d02bfc 36 fields · synced May 30, 2026