Identity
- Trade Name
- Universal Cannula FDA UDI
- Generic Name
- Cardiac sizing catheter FDA UDI
- Device Name
- The Universal Cannula is designed to provide a port of entry into the abdominal cavity during laparoscopic & endoscopic procedures. FDA UDI
- Model / Reference
- PS3506 FDA UDI
- Description
- The Universal Cannula is designed to provide a port of entry into the abdominal cavity during laparoscopic & endoscopic procedures. FDA UDI
Identifiers
- Catalog Number
- PS3506 FDA UDI
- Primary DI / UDI-DI
- 05051223003984 FDA UDI
- FDA Product Code
- HET FDA UDI
- GMDN Term
- Cardiac sizing catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1720 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Category: Cardiac sizing catheter
Universal Cannula by Purple Surgical International Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cardiac sizing catheter.
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- Amplatzer™ — ST. JUDE MEDICAL, INC. · Class II
- PTS-X™ — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class II
- PTS® — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class II
- PTS® — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class II
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
- Purple Surgical International Limited
Sources (1)
- FDA UDI fc7aae0b-d3d4-4c4f-a491-e6d49c762055 36 fields · synced May 30, 2026