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Zoellner Pen grip type, 2mm x 100mm, medial bend acute 30 degree angle, without…
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 74-2016PModel Surgical Drainage Systems
Identity
- Trade Name
- Zoellner Pen grip type, 2mm x 100mm, medial bend acute 30 degree angle, without control hole EUDAMEDZoellner Pen grip type, 2mm x 100mm, medial bend acute 30 degree angle, without FDA UDI
- Generic Name
- Surgical/emergency suction cannula, non-illuminating, single-use FDA UDI
- Model / Reference
- Surgical Drainage Systems EUDAMED74-2016P EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060411981850 EUDAMEDFDA UDI
- Basic UDI-DI
- 506021205TF39XT EUDAMED
- FDA Product Code
- JOL FDA UDI
- EMDN Code
- A06010103 CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE EUDAMED
- GMDN Term
- Surgical/emergency suction cannula, non-illuminating, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Zoellner Pen grip type, 2mm x 100mm, medial bend acute 30 degree angle, without… by Dtr Medical Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 506021205TF39XT | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Dtr Medical Ltd
- EUDAMED SRN
- GB-MF-000023112
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED da02968d-3253-4889-8c3d-59c2ead57e33 61 fields · synced Oct 6, 2026
- FDA UDI be33cdd0-b9d1-4ffd-b399-a7bf8f064234 32 fields · synced May 30, 2026