Identity
- Trade Name
- SURGICAL TROCAR EUDAMEDCleaning sheath for Ø4mm X 180mm 0° FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- Accessories Sinuscopy EUDAMEDcleaning sheath sinuscope FDA UDI
- Model / Reference
- 8300055821 EUDAMEDFDA UDI
- Description
- cleaning sheath sinuscope FDA UDI
Identifiers
- Catalog Number
- 8300055821 FDA UDI
- Primary DI / UDI-DI
- 04035873069355 EUDAMEDFDA UDI
- Basic UDI-DI
- 403587312030105AN EUDAMED
- Direct Marketing DI
- 04035873069355 EUDAMED
- FDA Product Code
- KMA FDA UDI
- EMDN Code
- L031280 SURGICAL TROCAR, REUSABLE - ACCESSORIES EUDAMED
- GMDN Term
- Endoscope sheath, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.5550 FDA UDI
- Market of Registration
- Germany 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
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Surgical Trocar by Henke-Sass, Wolf GmbH — Class IIa — 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 | 403587312030105AN | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Henke-Sass, Wolf GmbH
- EUDAMED SRN
- DE-MF-000005531
Sources (2)
- EUDAMED c0e2fc90-01f4-4bbf-aa6a-cda6869833f1 61 fields · synced Jun 18, 2026
- FDA UDI ef260f66-68cb-4ffe-8659-9dfa92fd9a31 35 fields · synced May 30, 2026