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Surgical insertion aids
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8383.00Model 10000201203
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- Surgical insertion aids EUDAMEDINTRODUCTION SLEEVE SZ 5.5MM WL 45MM with sealing cap, reusable FDA UDI
- Model / Reference
- 10000201203 EUDAMED8383.00 EUDAMED838300 FDA UDI
- Description
- INTRODUCTION SLEEVE SZ 5.5MM WL 45MM with sealing cap, reusable FDA UDI
Identifiers
- Catalog Number
- 8383.00 FDA UDI
- Primary DI / UDI-DI
- 04055207009802 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520723052019-0017948JG EUDAMED
- Direct Marketing DI
- 04055207009802 EUDAMED
- FDA Product Code
- HDC FDA UDI
- EMDN Code
- L031299 SURGICAL TROCAR, REUSABLE - OTHER EUDAMED
- GMDN Term
- Endoscope sheath, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 45 Millimeter FDA UDI
Surgical insertion aids by Richard Wolf GmbH — 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 | 405520723052019-0017948JG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Richard Wolf GmbH
- EUDAMED SRN
- DE-MF-000007048
Sources (2)
- EUDAMED dd78810b-4738-4dad-8417-a5f9f76ee14d 61 fields · synced Jun 19, 2026
- FDA UDI acdcbb42-dc1e-4bb3-9dd4-c3c5eb88670b 37 fields · synced May 30, 2026