Identity
- Trade Name
- Advance FDA UDI
- Generic Name
- Intravascular occluding balloon catheter, image-guided FDA UDI
- Device Name
- Advance, CS Coronary Sinus Infusion Catheter FDA UDI
- Model / Reference
- G34293 FDA UDI
- Description
- Advance, CS Coronary Sinus Infusion Catheter FDA UDI
Identifiers
- Catalog Number
- PTA5-35-135-5-2.0-RCSI FDA UDI
- Primary DI / UDI-DI
- 10827002342931 FDA UDI
- FDA Product Code
- DQY FDA UDI
- GMDN Term
- Intravascular occluding balloon catheter, image-guided FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Advance by Cook, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cook, Inc.
Sources (1)
- FDA UDI 849e571b-71b5-4fb7-adf4-04484996dec1 37 fields · synced Jun 6, 2026