Gen2

FDA UDI

Class I (US FDA UDI)

by Surgix Medical Llc

Identity

Trade Name: GEN2 FDA UDI
Generic Name: Scalpel handle, reusable FDA UDI
Device Name: HARDY TRANSSPHENOIDAL KNIFE HANDLE VERTICAL FDA UDI
Model / Reference: G2N49415 FDA UDI
Description: HARDY TRANSSPHENOIDAL KNIFE HANDLE VERTICAL FDA UDI

Identifiers

Catalog Number: G2N49415 FDA UDI
Primary DI / UDI-DI: G277G2N494150 FDA UDI
FDA Product Code: GZX FDA UDI
GMDN Term: Scalpel handle, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 882.4525 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 — 9.75 Inch FDA UDI

Category: Scalpel handle, reusable

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

Similar devices

Also classified as Scalpel handle, reusable.

HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
KNIFE HANDLE — SONTEC INSTRUMENTS, INC. · Class I
SCALPEL HANDLE #4 — W.H. Holden, Inc. · Class I
Surgical Direct — SURGICAL DIRECT, INC. · Class I
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
Anterior Disc Prep — SeaSpine Orthopedics Corporation · Class I
HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
Brasseler USA — Peter Brasseler Holdings, LLC · Class I

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 cd716d7d-d019-4858-8386-e02b29e8b667 36 fields · synced May 31, 2026