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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 counter-torque/rod-pushing instrument FDA UDI
Device Name
DEROTATOR EX0618040 STRGHT DOUBLE PIVOT FDA UDI
Model / Reference
EX0618040 FDA UDI
Description
DEROTATOR EX0618040 STRGHT DOUBLE PIVOT FDA UDI

Identifiers

Primary DI / UDI-DI
00763000222901 FDA UDI
FDA Product Code
HXC FDA UDI
GMDN Term
Orthopaedic counter-torque/rod-pushing instrument 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic counter-torque/rod-pushing instrument

Medtronic Reusable Instruments by Medtronic Sofamor Danek, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic counter-torque/rod-pushing instrument.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Sofamor Danek, Inc.

Sources (1)

  • FDA UDI e9c12e78-2eed-47a7-9f4d-472968c08d5c 34 fields · synced Jun 1, 2026