Identity
- Trade Name
- PULSAVAC® EUDAMEDFDA UDI
- Generic Name
- Surgical/orthopaedic lavage system power supply FDA UDI
- Device Name
- Wound Debridement (AC Power Supply) EUDAMEDPower Supply, IT FDA UDI
- Model / Reference
- 00-5150-350-05 EUDAMEDFDA UDI
- Description
- Power Supply, IT FDA UDI
Identifiers
- Catalog Number
- 00-5150-350-05 FDA UDI
- Primary DI / UDI-DI
- 00889024375079 EUDAMEDFDA UDI
- Basic UDI-DI
- 889024AEU2B EUDAMED
- FDA Product Code
- FQH FDA UDI
- EMDN Code
- A03010299 IRRIGATION CONTROLLERS - OTHER EUDAMED
- GMDN Term
- Surgical/orthopaedic lavage system power supply FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5475 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Pulsavac® by Zimmer Surgical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 889024AEU2B | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zimmer Surgical, Inc.
- EUDAMED SRN
- US-MF-000001150
- Authorised Representative
- Biomet Global Supply Chain Center B.V. NL-AR-000000422
Sources (2)
- EUDAMED 4c3dc1fa-109b-4b5e-98ac-0e55e16710a0 61 fields · synced Jul 21, 2026
- FDA UDI 64bb3c75-ddbc-4021-bb4d-5138bd308937 35 fields · synced May 30, 2026