Identity
- Trade Name
- ITOOL FDA UDI
- Generic Name
- Disposable surgical irrigation/aspiration system FDA UDI
- Device Name
- DISPOSABLE PULSE IRRIGATION KIT(APPLY TO TRUNK-M) FDA UDI
- Model / Reference
- 209-02 FDA UDI
- Description
- DISPOSABLE PULSE IRRIGATION KIT(APPLY TO TRUNK-M) FDA UDI
Identifiers
- Catalog Number
- 209-02 FDA UDI
- Primary DI / UDI-DI
- 06957277200968 FDA UDI
- FDA Product Code
- FQH FDA UDI
- GMDN Term
- Disposable surgical irrigation/aspiration system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5475 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
Yes
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
Itool by Apex (Guangzhou) Tools & Orthopedics Co. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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
- InterPulse — Stryker Corp. · Class II
- InterPulse — Stryker Corp. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Apex (Guangzhou) Tools & Orthopedics Co.
Sources (2)
- FDA UDI 526b83f2-cadb-48b3-a9e8-68f0e34f6165 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026