Identity
- Trade Name
- SurgiLav FDA UDI
- Generic Name
- Disposable surgical irrigation/aspiration system FDA UDI
- Device Name
- Plus Handpiece with High Flow Trauma Tip with Soft Cone Splash Shield FDA UDI
- Model / Reference
- 0207561000 FDA UDI
- Description
- Plus Handpiece with High Flow Trauma Tip with Soft Cone Splash Shield FDA UDI
Identifiers
- Catalog Number
- 0207561000 FDA UDI
- Primary DI / UDI-DI
- 04546540860514 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
No
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
SurgiLav by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Disposable surgical irrigation/aspiration system.
- 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
- AWI — Apex (Guangzhou) Tools & Orthopedics Co. · Class II
- TRUVIC Generator — Taiwan Biomaterial Co., Ltd. · Class II
- MicroPort® — Apex (Guangzhou) Tools & Orthopedics Co. · Class II
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
- Stryker Corp.
Sources (1)
- FDA UDI 5fccd018-2ecd-441c-9cff-7f04694227df 36 fields · synced May 30, 2026