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Single Use Professional

FDA UDI

Class II (US FDA UDI)

by Eakin Surgical Limited

Identity

Trade Name
Single Use Professional FDA UDI
Generic Name
Surgical irrigation/aspiration cannula, non-illuminating, single-use FDA UDI
Device Name
Fenestrated Rounded Frazier 9fg 5cm contains 25 units FDA UDI
Model / Reference
S457 FDA UDI
Description
Fenestrated Rounded Frazier 9fg 5cm contains 25 units FDA UDI

Identifiers

Catalog Number
S457 FDA UDI
Primary DI / UDI-DI
05055299108703 FDA UDI
FDA Product Code
GCX FDA UDI
GMDN Term
Surgical irrigation/aspiration cannula, non-illuminating, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6740 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

Yes

FDA UDI

Category: Surgical irrigation/aspiration cannula, non-illuminating, single-use

Single Use Professional by Eakin Surgical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical irrigation/aspiration cannula, non-illuminating, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Eakin Surgical Limited

Sources (1)

  • FDA UDI e73c4868-592f-4d47-8965-6185c2724aae 34 fields · synced May 30, 2026