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Catetere Toracico Silicone Ch 12
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 20812Model CATETERE TORACICO SILICONE CH 12
by Redax S.p.A.
Identity
- Trade Name
- CATETERE TORACICO SILICONE CH 12 EUDAMEDThoracic Catheter, Straight Fr 12 FDA UDI
- Generic Name
- Pleural catheter FDA UDI
- Device Name
- CATETERE TORACICO SILICONE CH 12 EUDAMEDThis device is a sterile and single-use. This product has the proximal end flute-lipped for a easier insertion. Each catheter is provided with a radiopaque line to allow radiographic visualization. Depth markings, made with silicone points, must be found to a predefined distance as per technical specification from the beginning of the draining part that corresponds to the last punching hole in order to ease the positioning and removal of the catheter itself. FDA UDI
- Model / Reference
- CATETERE TORACICO SILICONE CH 12 EUDAMED20812 EUDAMEDFDA UDI
- Description
- This device is a sterile and single-use. This product has the proximal end flute-lipped for a easier insertion. Each catheter is provided with a radiopaque line to allow radiographic visualization. Depth markings, made with silicone points, must be found to a predefined distance as per technical specification from the beginning of the draining part that corresponds to the last punching hole in order to ease the positioning and removal of the catheter itself. FDA UDI
Identifiers
- Catalog Number
- 20812 FDA UDI
- Primary DI / UDI-DI
- 08034139292809 EUDAMEDFDA UDI
- Basic UDI-DI
- 803413929DRAIN1bGH EUDAMED
- FDA Product Code
- GBX FDA UDI
- EMDN Code
- A0601010401 THORACIC DRAINAGES (STRAIGHT AND ANGLED) EUDAMED
- GMDN Term
- Pleural catheter 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
Catetere Toracico Silicone Ch 12 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 e1d88b9b-ad5a-45ff-a13c-1ae6c86199cd 61 fields · synced Jul 22, 2026
- FDA UDI 637aff1d-f9a1-4920-9f47-52b319ae47ec 36 fields · synced May 29, 2026