Identity
- Trade Name
- PRIMOPAC™ Diagnostic Catheterization Sets EUDAMEDSUPER TORQUE FDA UDI
- Generic Name
- Angiographic catheter, single-use FDA UDI
- Device Name
- PRIMOPAC™ Diagnostic Catheterization Sets EUDAMEDCATH PRIMOPAC FR5.2 STP FDA UDI
- Model / Reference
- 533-591P EUDAMED533591P FDA UDI
- Description
- CATH PRIMOPAC FR5.2 STP FDA UDI
Identifiers
- Catalog Number
- 533591P FDA UDI
- Primary DI / UDI-DI
- 10705032012942 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10705032012942 EUDAMED
- FDA Product Code
- OEZ FDA UDI
- EMDN Code
- C0104010101 CARDIAC ANGIOGRAPHY DIAGNOSTIC CATHETERS EUDAMED
- GMDN Term
- Angiographic catheter, single-use FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1200 FDA UDI
- Market of Registration
- Netherlands 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: Angiographic catheter, single-use
Super Torque by Cordis Corp. — Class II — MDD, 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
- Torcon NB — COOK INCORPORATED · Class II
- Performa® — Merit Medical Systems, Inc. · Class II
- ConcierGE Guiding Excellence™ — Merit Medical Systems, Inc. · Class II
- INFINITI — Cordis US Corp. · Class II
- CXI — COOK INCORPORATED · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cordis Corp.
Sources (2)
- FDA UDI f0e13c01-a659-4bcf-ad33-129f8d92aa92 34 fields · synced Jun 19, 2026
- EUDAMED c160ed37-ee6c-456d-8df8-a5fcd4c75ba9 61 fields · synced Jun 19, 2026