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Silicone Penrose Drain Tube W/ Secure-Clip
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2010-6419Ref 2010-5408Ref 2010-6408Ref 2010-6415Ref 2010-6406Ref 2010-6412
Identity
- Trade Name
- Silicone Penrose Drain Tube W/ Secure-Clip EUDAMEDSilicone Penrose Drain Tube FDA UDI
- Generic Name
- Surgical capillary wound drain, luminal, synthetic polymer FDA UDI
- Device Name
- Silicone Penrose Drain Tube W/ Secure-Clip EUDAMED
- Model / Reference
- 2010-6419 EUDAMEDFDA UDI2010-5408 EUDAMED2010-6408 EUDAMED2010-6415 EUDAMED2010-6406 EUDAMED2010-6412 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14711182604957 EUDAMEDFDA UDI04711182604950 EUDAMED14711182604834 EUDAMED04711182604912 EUDAMED04711182604943 EUDAMED04711182604905 EUDAMED04711182604936 EUDAMED04711182604837 EUDAMED
- Basic UDI-DI
- B-14711182604957 EUDAMEDB-04711182604950 EUDAMEDB-14711182604834 EUDAMEDB-04711182604912 EUDAMEDB-04711182604943 EUDAMEDB-04711182604905 EUDAMEDB-04711182604936 EUDAMEDB-04711182604837 EUDAMED
- FDA Product Code
- GCD FDA UDI
- EMDN Code
- A06010199 VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER EUDAMED
- GMDN Term
- Surgical capillary wound drain, luminal, synthetic polymer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Market of Registration
- Romania EUDAMEDDenmark 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Silicone Penrose Drain Tube W/ Secure-Clip by Fortune Medical Instrument Corp. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-14711182604957 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
- EUDAMED SRN
- TW-MF-000009221
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (9)
- EUDAMED d2589dfd-f6fe-4bd5-9584-bd437c9dcbad 61 fields · synced Jul 30, 2026
- EUDAMED 260f2325-7cfb-4fd9-8e54-624b9e612e5f 61 fields · synced May 16, 2026
- EUDAMED 826fb0cf-087c-4eeb-a3e0-7161f363ca41 61 fields · synced May 17, 2026
- EUDAMED b60be6e3-ced3-4460-9b35-c6beda936f33 61 fields · synced May 17, 2026
- EUDAMED 66c8daf9-7026-45a6-a4bf-413fbf8ef933 61 fields · synced May 18, 2026
- EUDAMED 783c3ab8-0a87-478c-86fb-6b8cc6e6f49a 61 fields · synced May 19, 2026
- EUDAMED c52f7db0-8f8f-4e2f-92e6-ac97bee18901 61 fields · synced May 19, 2026
- EUDAMED 83f89285-0bd5-45c6-ba17-b556cda5c136 61 fields · synced May 19, 2026
- FDA UDI 3101916a-a4e7-48b6-b475-467922a97379 32 fields · synced May 30, 2026