Identity
- Trade Name
- Pathfinder Plus FDA UDI
- Generic Name
- Surgical irrigation tubing set, single-use FDA UDI
- Device Name
- Continuous and Plsatile Irrigation Bulb FDA UDI
- Model / Reference
- Ureteroscopy Irrigation Bulb FDA UDI
- Description
- Continuous and Plsatile Irrigation Bulb FDA UDI
Identifiers
- Catalog Number
- PA701 FDA UDI
- Primary DI / UDI-DI
- H671PA7010 FDA UDI
- 510(k) Number
- K001874 FDA UDI
- FDA Product Code
- LJS FDA UDI
- GMDN Term
- Surgical irrigation tubing set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5970 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: Surgical irrigation tubing set, single-use
Pathfinder Plus by Utah Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical irrigation tubing set, single-use.
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- Endo-Flo — Davol Inc. · Class II
Cleared under the same submission
K001874 also covers:
- PICC-NATE — Utah Medical Products, Inc.
- PICC-NATE — Utah Medical Products, Inc.
- PICC-NATE — Utah Medical Products, Inc.
- PICC-NATE — Utah Medical Products, Inc.
- PICC-NATE — Utah Medical Products, Inc.
- PICC-NATE — Utah Medical Products, Inc.
- PICC-NATE — Utah Medical Products, Inc.
- PICC-NATE — Utah Medical Products, Inc.
- PICC-NATE — Utah Medical Products, Inc.
- PICC-NATE — Utah Medical Products, Inc.
- PICC-NATE — Utah Medical Products, Inc.
- PICC-NATE — Utah Medical Products, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Utah Medical Products, Inc.
Sources (1)
- FDA UDI c2b001a9-2640-4efb-b7db-efa07b60b595 36 fields · synced Jun 9, 2026