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Medtronic Resuable Instruments

FDA UDI

Class I (US FDA UDI)

by Medtronic Sofamor Danek, Inc.

Identity

Trade Name
Medtronic Resuable Instruments FDA UDI
Generic Name
Orthopaedic rod reducer FDA UDI
Device Name
ROD HOLDER EX0217082 3.5MM FDA UDI
Model / Reference
EX0217082 FDA UDI
Description
ROD HOLDER EX0217082 3.5MM FDA UDI

Identifiers

Primary DI / UDI-DI
00643169986381 FDA UDI
FDA Product Code
HTC FDA UDI
GMDN Term
Orthopaedic rod reducer FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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 rod reducer

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

Similar devices

Also classified as Orthopaedic rod reducer.

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 80891bf4-167b-4a9c-ba3f-1cc0a189d130 34 fields · synced Jun 6, 2026