UniSyn Hip System

FDA UDI

Class I (US FDA UDI)

by Shalby Advanced Technologies, Inc.

Identity

Trade Name: UniSyn Hip System FDA UDI
Generic Name: Medullary canal orthopaedic reamer, rigid FDA UDI
Device Name: UniSyn, Plus, Reamer, Std, RH, Straight, Helical, 18mm FDA UDI
Model / Reference: 4430-20180-B FDA UDI
Description: UniSyn, Plus, Reamer, Std, RH, Straight, Helical, 18mm FDA UDI

Identifiers

Catalog Number: 4430-20180-B FDA UDI
Primary DI / UDI-DI: 00840286844291 FDA UDI
FDA Product Code: HTO FDA UDI
KIJ FDA UDI
GMDN Term: Medullary canal orthopaedic reamer, rigid FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
878.4820 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: Medullary canal orthopaedic reamer, rigid

UniSyn Hip System by Shalby Advanced Technologies, Inc. — 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: Shalby Advanced Technologies, Inc.

Sources (1)

FDA UDI b369746d-8b14-47d8-9b57-2b77e799a33c 36 fields · synced Jun 8, 2026