Identity
- Trade Name
- TRUCLEARTM FDA UDI
- Generic Name
- Hysteroscopic irrigation/insufflation system FDA UDI
- Device Name
- CALIBRATION INSERT DISPOSABLE FDA UDI
- Model / Reference
- 7211067 FDA UDI
- Description
- CALIBRATION INSERT DISPOSABLE FDA UDI
Identifiers
- Catalog Number
- 7211067 FDA UDI
- Primary DI / UDI-DI
- 03596010529497 FDA UDI
- 510(k) Number
- K031616 FDA UDI
- FDA Product Code
- HIG FDA UDI
- GMDN Term
- Hysteroscopic irrigation/insufflation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1700 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: Hysteroscopic irrigation/insufflation system
Trucleartm by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Hysteroscopic irrigation/insufflation system.
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- Aquilex® Fluid Control System — W.O.M. World of Medicine GmbH · Class II
- Premier — PREMIER DENTAL PRODUCTS COMPANY · Class II
- TruClear — Covidien LP · Class II
- Premier — PREMIER DENTAL PRODUCTS COMPANY · Class II
Cleared under the same submission
K031616 also covers:
- Hysteroscopic Fluid Management — Smith & Nephew, Inc.
- Hysteroscopic Fluid Management — Smith & Nephew, Inc.
- Hysteroscopic Fluid Management — Smith & Nephew, Inc.
- Hysteroscopic Fluid Management System Stand — Smith & Nephew, Inc.
- Hysteroscopic Inflow Tube Set — Smith & Nephew, Inc.
- Hysteroscopic Outflow Tube Set — Smith & Nephew, Inc.
- Hysteroscopic Roller Base — Smith & Nephew, Inc.
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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI e97e6d58-d04c-40df-bad0-fd7282d8f6b8 36 fields · synced Jun 8, 2026