Identity
- Trade Name
- Viscous Fluid Pack FDA UDI
- Generic Name
- Eye-surface lavage system FDA UDI
- Device Name
- Single-use procedure pack for injection and aspiration of silicone oil and other viscous fluids. Connects to Alcon systems. Pack includes 10cc syringe with pressure-tested tubing and adapters, stainless steel cannula, and Teflon cannula. 0.2 micron filter included to maintain sterile field. Sterile, single-use. FDA UDI
- Model / Reference
- 8170-51 FDA UDI
- Description
- Single-use procedure pack for injection and aspiration of silicone oil and other viscous fluids. Connects to Alcon systems. Pack includes 10cc syringe with pressure-tested tubing and adapters, stainless steel cannula, and Teflon cannula. 0.2 micron filter included to maintain sterile field. Sterile, single-use. FDA UDI
Identifiers
- Catalog Number
- TR8170-51 FDA UDI
- Primary DI / UDI-DI
- 00853480006242 FDA UDI
- 510(k) Number
- K963434 FDA UDI
- FDA Product Code
- MRH FDA UDI
- GMDN Term
- Eye-surface lavage system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 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: Eye-surface lavage system
Viscous Fluid Pack by Escalon Medical Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Eye-surface lavage system.
- Kera-Flow — Esi, Inc. · Class I
- Viscous Fluid Pack — ESCALON MEDICAL CORP · Class II
Cleared under the same submission
K963434 also covers:
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
- Escalon Medical Corp
Sources (1)
- FDA UDI ca2961b8-4f9d-4125-970f-5134746734a9 37 fields · synced Jun 8, 2026