Gen2

FDA UDI

Class I (US FDA UDI)

by Surgix Medical Llc

Identity

Trade Name: GEN2 FDA UDI
Generic Name: Ear knife FDA UDI
Device Name: SHEA INCISION KNIFE 6 1/4" FDA UDI
Model / Reference: G2E901156 FDA UDI
Description: SHEA INCISION KNIFE 6 1/4" FDA UDI

Identifiers

Catalog Number: G2E901156 FDA UDI
Primary DI / UDI-DI: 00840343720025 FDA UDI
FDA Product Code: KTG FDA UDI
GMDN Term: Ear knife FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4420 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 6.25 Inch FDA UDI

Category: Ear knife

Gen2 by Surgix Medical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Surgix Medical Llc

Sources (1)

FDA UDI eec91253-a4e3-4ec1-b6bf-3c148f95b442 36 fields · synced May 30, 2026