Identity
- Trade Name
- Speculum, Rectal Kit FDA UDI
- Generic Name
- Colonic lavage kit, non-surgical FDA UDI
- Device Name
- Speculum, Rectal Straight Style Large Speculum Kit ~ 1/4 inflow hose ~ 48 waste hose ~ G-Hose ~ 5g surgical lube packet, California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 923478C1 (Class I Device7 FDA UDI
- Model / Reference
- SPO1 Large Straight 1448 G-Hose FDA UDI
- Description
- Speculum, Rectal Straight Style Large Speculum Kit ~ 1/4 inflow hose ~ 48 waste hose ~ G-Hose ~ 5g surgical lube packet, California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 923478C1 (Class I Device7 FDA UDI
Identifiers
- Catalog Number
- 923478C1 FDA UDI
- Primary DI / UDI-DI
- B424923478C1 FDA UDI
- FDA Product Code
- FFQ FDA UDI
- GMDN Term
- Colonic lavage kit, non-surgical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4730 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 6 Inch FDA UDI
Category: Colonic lavage kit, non-surgical
Speculum, Rectal Kit by Clearwater Colon Hydrotherapy, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Clearwater Colon Hydrotherapy, Inc.
Sources (1)
- FDA UDI e6f1d65d-56cd-41a5-92ef-c054f241207d 37 fields · synced May 30, 2026