Beacon Tip Torcon NB
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Beacon® Tip EUDAMEDBeacon Tip Torcon NB FDA UDI
- Generic Name
- Angiographic catheter, single-use FDA UDI
- Device Name
- "Diagnostic Visceral Catheters [Beacon® Tip Angiographic Catheter; Torcon Angiographic Catheter] " EUDAMEDBeacon Tip Torcon NB Advantage Catheter FDA UDI
- Model / Reference
- HNBR5.0-35-90-P-NS-RBT EUDAMEDG08796 FDA UDIG57017 FDA UDI
- Description
- Beacon Tip Torcon NB Advantage Catheter FDA UDI
Identifiers
- Catalog Number
- HNBR5.0-35-100-P-NS-C2 FDA UDIHNBR5.0-35-90-P-NS-RBT FDA UDI
- Primary DI / UDI-DI
- 00827002570177 EUDAMEDFDA UDI00827002087965 FDA UDI
- Basic UDI-DI
- 0827002CINC012-021_B2W5 EUDAMED
- 510(k) Number
- K173289 FDA UDI
- FDA Product Code
- DQO FDA UDI
- EMDN Code
- C0104020101 PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS EUDAMED
- GMDN Term
- Angiographic catheter, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1200 FDA UDI
- Market of Registration
- Germany 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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Angiographic catheter, single-use
Beacon Tip Torcon NB by Cook Incorporated — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Angiographic catheter, single-use.
- INFINITI — Cordis US Corp. · Class II
- Performa® — Merit Medical Systems, Inc. · Class II
- Performa® — Merit Medical Systems, Inc. · Class II
- Performa® — Merit Medical Systems, Inc. · Class II
- ConcierGE Guiding Excellence™ — Merit Medical Systems, Inc. · Class II
- INFINITI — Cordis US Corp. · Class II
- SUPER TORQUE — Cordis Corp. · Class II
- Performa® — Merit Medical Systems, Inc. · Class II
Cleared under the same submission
K173289 also covers:
- Beacon — COOK INCORPORATED
- Beacon — COOK INCORPORATED
- Beacon — COOK INCORPORATED
- Beacon — COOK INCORPORATED
- Beacon Tip Torcon NB — COOK INCORPORATED
- Beacon Tip Torcon NB — COOK INCORPORATED
- Beacon Tip Torcon NB — COOK INCORPORATED
- Beacon Tip Torcon NB — COOK INCORPORATED
- Beacon Tip Torcon NB — COOK INCORPORATED
- Beacon Tip Torcon NB — COOK INCORPORATED
- Beacon Tip Torcon NB — COOK INCORPORATED
- Beacon Tip Torcon NB — COOK INCORPORATED
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cook Incorporated
Sources (3)
- FDA UDI 3ccc8b41-b408-4303-9863-2178573956e5 37 fields · synced Aug 1, 2026
- FDA UDI 341f77e0-22ae-40f1-a3a6-56908182489b 37 fields · synced May 30, 2026
- EUDAMED df58ed7c-9ffe-4a8e-a26e-823ca4f4363e 61 fields · synced Aug 1, 2026