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Drenaggio piatto tipo Jackson Pratt con ago 3x7 mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 24101Model CATETERE TORACICO SILICONE CH 12
by Redax S.p.A.
Identity
- Trade Name
- Drenaggio piatto tipo Jackson Pratt con ago 3x7 mm EUDAMEDFlat Drain 3/4 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 3/4 profile juctionless with connecting tube allowing continuous and constant drainage, reducing risk of occlusion. 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 EUDAMED24101 EUDAMEDFDA UDI
- Description
- The surgical drainage is a sterile and single-use device. Flat 3/4 profile juctionless with connecting tube allowing continuous and constant drainage, reducing risk of occlusion. 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
- 24101 FDA UDI
- Primary DI / UDI-DI
- 08034139294513 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
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
Similar devices
Also classified as Closed-wound drain, non-bioabsorbable.
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- Exodus — NAVILYST MEDICAL, INC. · Class II
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 77e35280-6a37-40e0-9f88-1ada9eace6ec 61 fields · synced Jul 26, 2026
- FDA UDI 06471711-9625-45c7-aee5-001e32790f0e 36 fields · synced May 30, 2026