Medtronic Reusable Instruments

FDA UDI

Class I (US FDA UDI)

by Medtronic Sofamor Danek, Inc.

Identity

Trade Name: Medtronic Reusable Instruments FDA UDI
Generic Name: Orthopaedic surgical distractor, internal FDA UDI
Device Name: DISTRACTOR EX0219045 7MM TAL 21MM WD WDG FDA UDI
Model / Reference: EX0219045 FDA UDI
Description: DISTRACTOR EX0219045 7MM TAL 21MM WD WDG FDA UDI

Identifiers

Primary DI / UDI-DI: 00763000256685 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Orthopaedic surgical distractor, internal 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: Orthopaedic surgical distractor, internal

Medtronic Reusable Instruments by Medtronic Sofamor Danek, 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: Medtronic Sofamor Danek, Inc.

Sources (1)

FDA UDI b971a968-e93f-4a9d-b585-3d4533549d2b 34 fields · synced Jun 6, 2026