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Drenaggio piatto tipo Jackson Pratt con ago 4x10 mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 24131Model CATETERE TORACICO SILICONE CH 12
by Redax S.p.A.
Identity
- Trade Name
- Drenaggio piatto tipo Jackson Pratt con ago 4x10 mm EUDAMEDFlat Drain type Jackson-Pratt w/trocar 4x10 mm FDA UDI
- Generic Name
- Closed-wound drain, non-bioabsorbable FDA UDI
- Device Name
- CATETERE TORACICO SILICONE CH 12 EUDAMEDThe surgical drainage is a sterile and single-use device. Flat low profile helps promote tissue plane approximation. The drainage has depth markings, graduated from the end of the perforated section: these markings facilitate accurate positioning of the drainage in the wound. The drainage is biocompatible and hemocompatible (in accordance with the regulations in force). The product is compatible for use with gravity or suction drainage systems. FDA UDI
- Model / Reference
- CATETERE TORACICO SILICONE CH 12 EUDAMED24131 EUDAMEDFDA UDI
- Description
- The surgical drainage is a sterile and single-use device. Flat low profile helps promote tissue plane approximation. The drainage has depth markings, graduated from the end of the perforated section: these markings facilitate accurate positioning of the drainage in the wound. The drainage is biocompatible and hemocompatible (in accordance with the regulations in force). The product is compatible for use with gravity or suction drainage systems. FDA UDI
Identifiers
- Catalog Number
- 24131 FDA UDI
- Primary DI / UDI-DI
- 08034139294575 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 piatto tipo Jackson Pratt con ago 4x10 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 24ff2956-f3b2-411b-af8c-def848a0e53d 61 fields · synced Jun 20, 2026
- FDA UDI 8762e9ae-5f22-4216-957b-862ebb03b9bb 36 fields · synced May 30, 2026