Identity
- Trade Name
- TRUVIC Generator FDA UDI
- Generic Name
- Disposable surgical irrigation/aspiration system FDA UDI
- Device Name
- TRUVIC Canister (White Lid), PTC001B FDA UDI
- Model / Reference
- PTC001B FDA UDI
- Description
- TRUVIC Canister (White Lid), PTC001B FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719876940100 FDA UDI
- 510(k) Number
- K190105 FDA UDI
- FDA Product Code
- JCX FDA UDI
- GMDN Term
- Disposable surgical irrigation/aspiration system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 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
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: Disposable surgical irrigation/aspiration system
TRUVIC Generator by Taiwan Biomaterial Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Disposable surgical irrigation/aspiration system.
- SurgiLav — Stryker Corp. · Class II
- InterPulse — Stryker Corp. · Class II
- SIMPULSE — Davol Inc. · Class II
- ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
- CLEANEST — Guangzhou Clean Medical Products Manufacturing Corp. · Class II
- Irrigation Set — Omnia Spa · Class I
- AWI — Apex (Guangzhou) Tools & Orthopedics Co. · Class II
- InterPulse — Stryker Corp. · Class II
Cleared under the same submission
K190105 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 |
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Manufacturer
- Manufacturer
- Taiwan Biomaterial Co., Ltd.
Sources (1)
- FDA UDI 1e87e40a-e53f-4577-a962-2e19107de18d 35 fields · synced May 30, 2026