Drenaggio scanalato piatto 4 x 10 mm
EUDAMEDFDA UDIClass IIa (EU MDR)
by Redax S.p.A.
Identity
- Trade Name
- Drenaggio scanalato piatto 4 x 10 mm EUDAMEDFlat Fluted Drain 4x10 mm FDA UDI
- Generic Name
- Closed-wound drain, non-bioabsorbable FDA UDI
- Device Name
- CATETERE TORACICO SILICONE CH 12 EUDAMEDA sterile and single-use silicone device characterized by a flat low profile to promote a tissue plane approximation. FDA UDI
- Model / Reference
- CATETERE TORACICO SILICONE CH 12 EUDAMED24622 EUDAMEDFDA UDI
- Description
- A sterile and single-use silicone device characterized by a flat low profile to promote a tissue plane approximation. FDA UDI
Identifiers
- Catalog Number
- 24622 FDA UDI
- Primary DI / UDI-DI
- 08034139295060 EUDAMEDFDA UDI
- Basic UDI-DI
- 803413929DRAIN1bGH EUDAMED
- FDA Product Code
- GBX FDA UDI
- EMDN Code
- A0601010403 FLAT AND LAMELLAR DRAINAGES EUDAMED
- GMDN Term
- Closed-wound drain, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Closed-wound drain, non-bioabsorbable
Drenaggio scanalato piatto 4 x 10 mm by Redax S.p.A. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803413929DRAIN1bGH | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Redax S.p.A.
- EUDAMED SRN
- IT-MF-000019320
Sources (2)
- EUDAMED 97f860f8-3633-4928-877b-a30f26d95edf 61 fields · synced Jun 19, 2026
- FDA UDI 465ba80d-8f07-4f17-a393-ae225b870a01 36 fields · synced May 25, 2026