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Gen2

FDA UDI

Class I (US FDA UDI)

by Surgix Medical Llc

Identity

Trade Name
GEN2 FDA UDI
Generic Name
Open-surgery dissector FDA UDI
Device Name
RHOTON MICRO RIGHT ANG HOOK, SHARP FDA UDI
Model / Reference
G2N49309 FDA UDI
Description
RHOTON MICRO RIGHT ANG HOOK, SHARP FDA UDI

Identifiers

Catalog Number
G2N49309 FDA UDI
Primary DI / UDI-DI
G277G2N493090 FDA UDI
FDA Product Code
GDG FDA UDI
GMDN Term
Open-surgery dissector FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 19 Centimeter FDA UDI

Category: Open-surgery dissector

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

Similar devices

Also classified as Open-surgery dissector.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Surgix Medical Llc

Sources (1)

  • FDA UDI dd419790-ab3b-4529-a85c-cf68c410f8e7 36 fields · synced Jun 6, 2026