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Drenaggio scanalato piatto 3 x 7 mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 24625Model CATETERE TORACICO SILICONE CH 12
by Redax S.p.A.
Identity
- Trade Name
- Drenaggio scanalato piatto 3 x 7 mm EUDAMEDFlat Fluted Drain w/trocar 3x7 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 EUDAMED24625 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
- 24625 FDA UDI
- Primary DI / UDI-DI
- 08034139295091 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
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
No
FDA UDI
Drenaggio scanalato piatto 3 x 7 mm by Redax S.p.A. — 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 | 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 0e9d5153-0633-49bc-ab58-0e08f7990e84 61 fields · synced Jun 19, 2026
- FDA UDI 6b353f01-73d8-4113-b4a1-166db639f96b 36 fields · synced May 30, 2026