Identity
- Trade Name
- Viscous Fluid Cannula FDA UDI
- Generic Name
- Ophthalmic cannulation set, single-use FDA UDI
- Device Name
- A 4 mm beveled tip infusion cannula used as an aid for infusing fluid into the posterior chamber of the eye, and is particularly designed for use with high-viscosity fluids. The flanged cannula is designed to easily suture into place and is qualified for use at operating pressures of up to 70 psi. Sterile, Single Use FDA UDI
- Model / Reference
- 9849-51 FDA UDI
- Description
- A 4 mm beveled tip infusion cannula used as an aid for infusing fluid into the posterior chamber of the eye, and is particularly designed for use with high-viscosity fluids. The flanged cannula is designed to easily suture into place and is qualified for use at operating pressures of up to 70 psi. Sterile, Single Use FDA UDI
Identifiers
- Catalog Number
- TR9849-51 FDA UDI
- Primary DI / UDI-DI
- 00853480006167 FDA UDI
- FDA Product Code
- HMX FDA UDI
- GMDN Term
- Ophthalmic cannulation set, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic cannulation set, single-use
Viscous Fluid Cannula by Escalon Medical Corp — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic cannulation set, single-use.
- Disposable One Step Cannula System (25 gauge/0.5 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
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- MANI Trocar Kit — MANI, INC. · Class I
- Kaiser Permanente Kit Pack — OASIS Medical, Inc. · Class I
- ALCON — Alcon Laboratories, Inc. · Class I
- 23G Cannula set with High Flow infusion line — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
- Disposable one step single cannula including inserter. (27 gauge / 0.4 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
- Kaiser Permanente Kit Pack — OASIS Medical, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Escalon Medical Corp
Sources (1)
- FDA UDI 46dabb33-1db1-4397-9939-dd43601ab423 35 fields · synced Jun 1, 2026