Identity
- Trade Name
- debritom+ FDA UDI
- Generic Name
- Surgical irrigation system nozzle FDA UDI
- Device Name
- debritom+ pump, one day FDA UDI
- Model / Reference
- 2000.0201 FDA UDI
- Description
- debritom+ pump, one day FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07649996166050 FDA UDI
- FDA Product Code
- FQH FDA UDI
- GMDN Term
- Surgical irrigation system nozzle 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: Surgical irrigation system nozzle
debritom+ by Medaxis AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation system nozzle.
- AWI — Apex (Suzhou) Medical Products Company · Class II
- De Soutter Medical — De Soutter Medical, Ltd. · Class II
- De Soutter Medical — De Soutter Medical, Ltd. · Class II
- De Soutter Medical — De Soutter Medical, Ltd. · Class II
- Super Bypass — TAKAYAMA INSTRUMENTS INC. · Class I
- Super Bypass — TAKAYAMA INSTRUMENTS INC. · Class I
- itool® ApexPulse™ — Apex (Guangzhou) Tools & Orthopedics Co. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · 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
- Medaxis AG
Sources (1)
- FDA UDI 641dc111-ec6d-4ec6-b196-1437e1ce28a1 34 fields · synced May 30, 2026