Drenaggio piatto tipo Jackson Pratt con ago 3x7 mm
EUDAMEDFDA UDIClass IIa (EU MDR)
by Redax S.p.A.
Identity
- Trade Name
- Drenaggio piatto tipo Jackson Pratt con ago 3x7 mm EUDAMEDFlat Drain type Jackson-Pratt 3x7 mm w/trocar 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 EUDAMED24111 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
- 24111 FDA UDI
- Primary DI / UDI-DI
- 08034139294537 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 piatto tipo Jackson Pratt con ago 3x7 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 cbc71148-8f97-46ec-8705-abaeb17f8c30 61 fields · synced Jul 31, 2026
- FDA UDI 0f1f633a-da27-4989-b088-c90ea742dbac 36 fields · synced May 29, 2026