Identity
- Trade Name
- VTI Remotely Operated Suction & Irrigation System FDA UDI
- Generic Name
- Surgical irrigation/aspiration pump, reusable FDA UDI
- Device Name
- PART NUMBER 106400 VTI Remotely Operated Suction & Irrigation System Device FDA UDI
- Model / Reference
- 106400 FDA UDI
- Description
- PART NUMBER 106400 VTI Remotely Operated Suction & Irrigation System Device FDA UDI
Identifiers
- Catalog Number
- 106400 FDA UDI
- Primary DI / UDI-DI
- 00817122020065 FDA UDI
- 510(k) Number
- K141323 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Surgical irrigation/aspiration pump, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Surgical irrigation/aspiration pump, reusable
VTI Remotely Operated Suction & Irrigation System by Vascular Technology Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation/aspiration pump, reusable.
- ENDOMAT — Karl Storz GmbH & Co. KG · Class II
- CrossFlow — Stryker Corp. · Class II
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- Riptide™ — Micro Therapeutics, Inc. · Class II
- Tech Medical Services — TECH MEDICAL SERVICES, INC. · Class I
- CORE — Stryker Corp. · Class II
- ERBE — Erbe Elektromedizin GmbH · Class II
- AHTO — Stryker Corp. · Class II
Cleared under the same submission
K141323 also covers:
- CUFF:INFLATION FOR ROSI — VASCULAR TECHNOLOGY INCORPORATED
- FOOT SWITCH ASSEMBLY FOR ROSI — VASCULAR TECHNOLOGY INCORPORATED
- Latching Foot Switch for Use with 106400 — VASCULAR TECHNOLOGY INCORPORATED
- POWER SUPPLY: ASSEMBLY FOR ROSI — VASCULAR TECHNOLOGY INCORPORATED
- ROSI xT Tubing set for use with Exchangable Tips — VASCULAR TECHNOLOGY INCORPORATED
- Remotely Operated Suction & Irrigation Tubing Set, Box — VASCULAR TECHNOLOGY INCORPORATED
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
- Vascular Technology Incorporated
Sources (1)
- FDA UDI 9c9b084a-8d91-4031-8416-40f585abdddb 37 fields · synced Jun 1, 2026