Gen2

FDA UDI

Class I (US FDA UDI)

by Surgix Medical Llc

Identity

Trade Name: GEN2 FDA UDI
Generic Name: Hand-held surgical retractor, reusable FDA UDI
Device Name: DARRACH RETRACTOR 260MM x 12MM 10 1/4" FDA UDI
Model / Reference: G2N99446 FDA UDI
Description: DARRACH RETRACTOR 260MM x 12MM 10 1/4" FDA UDI

Identifiers

Catalog Number: G2N99446 FDA UDI
Primary DI / UDI-DI: 00840343715809 FDA UDI
FDA Product Code: GAD FDA UDI
GMDN Term: Hand-held surgical retractor, reusable 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

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 — 10.5 Inch FDA UDI
Width — 12 Millimeter FDA UDI

Category: Hand-held surgical retractor, reusable

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 39ff7283-70d4-4aed-a2a4-076458f6848d 36 fields · synced May 31, 2026