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Probe

FDA UDI

Class II (US FDA UDI)

by Genicon

Identity

Trade Name
Probe FDA UDI
Generic Name
Surgical irrigation/aspiration cannula, non-illuminating, single-use FDA UDI
Model / Reference
700-005-045 FDA UDI

Identifiers

Primary DI / UDI-DI
00877972007319 FDA UDI
510(k) Number
K041967 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Surgical irrigation/aspiration cannula, non-illuminating, single-use 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

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

Probe by Genicon — 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.

Cleared under the same submission

K041967 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Genicon

Sources (1)

  • FDA UDI 4ed13146-8249-479d-bab6-fbb01dc41372 33 fields · synced May 30, 2026