Surgical Direct

FDA UDI

Class I (US FDA UDI)

by Surgical Direct, Inc.

Identity

Trade Name: Surgical Direct FDA UDI
Generic Name: Spinal rongeur FDA UDI
Device Name: 3.4mm, Hook Scissors, Straight, Ring Handle FDA UDI
Model / Reference: SD48-2503 FDA UDI
Description: 3.4mm, Hook Scissors, Straight, Ring Handle FDA UDI

Identifiers

Catalog Number: SD48-2503 FDA UDI
Primary DI / UDI-DI: B382SD4825030 FDA UDI
FDA Product Code: HTX FDA UDI
GMDN Term: Spinal rongeur FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

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

Category: Spinal rongeur

Surgical Direct by Surgical Direct, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal rongeur.

Avalign — AVALIGN TECHNOLOGIES, Inc. · Class II
Sklar — Sklar Corporation · Class I
Avalign — AVALIGN TECHNOLOGIES, Inc. · Class II
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
V. Mueller — STERIS CORPORATION · Class II
Boss Instruments — Boss Instruments, Ltd. · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Surgical Direct, Inc.

Sources (1)

FDA UDI 50fb02b6-6783-4ed7-b322-7f2e38bee83d 35 fields · synced Jun 1, 2026