Mega5.5 Spine System

FDA UDI

Class I (US FDA UDI)

by Bk Meditech Co., Ltd.

Identity

Trade Name: MEGA5.5 SPINE SYSTEM FDA UDI
Generic Name: Surgical torque wrench, reusable FDA UDI
Device Name: Wrench 4.0 FDA UDI
Model / Reference: 81633 FDA UDI
Description: Wrench 4.0 FDA UDI

Identifiers

Primary DI / UDI-DI: 08809763500343 FDA UDI
FDA Product Code: HXC FDA UDI
GMDN Term: Surgical torque wrench, reusable 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

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

Category: Surgical torque wrench, reusable

Mega5.5 Spine System by Bk Meditech Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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OXFORD ANKLE FUSION NAIL(AFN) SYSTEM — ORTHO SOLUTIONS HOLDINGS LIMITED · Class II
X FIX — Biomet Orthopedics, Inc. · Class I
BIONNOVATION — BIONNOVATION PRODUTOS BIOMEDICOS LTDA. · 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: Bk Meditech Co., Ltd.

Sources (1)

FDA UDI b7f898de-baa0-48b4-a916-45699039ef62 33 fields · synced May 30, 2026