Identity
- Trade Name
- debritom+ FDA UDI
- Generic Name
- Surgical/orthopaedic lavage control unit FDA UDI
- Device Name
- debritom+ micro water jet device FDA UDI
- Model / Reference
- 1000.0005 FDA UDI
- Description
- debritom+ micro water jet device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07649996166036 FDA UDI
- FDA Product Code
- FQH FDA UDI
- GMDN Term
- Surgical/orthopaedic lavage control unit 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical/orthopaedic lavage control unit
debritom+ by Medaxis AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical/orthopaedic lavage control unit.
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- Affinity with accessories — TAVGER LTD · Class II
- MicroAire® — MicroAire Surgical Instruments LLC · Class II
- POWERPULSE — Smith & Nephew, Inc. · Class II
- MicroAire® — MicroAire Surgical Instruments LLC · 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 |
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Manufacturer
- Manufacturer
- Medaxis AG
Sources (1)
- FDA UDI 15aa4e1f-0068-4463-85c6-60c5920e7bd8 34 fields · synced May 30, 2026