Accuguide®

FDA UDI

Class II (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name: Accuguide® FDA UDI
Generic Name: Nerve-locating system FDA UDI
Device Name: SOFTWARE 8263005 ACCUGUIDE MONIT V2.0 CD FDA UDI
Model / Reference: 8263005 FDA UDI
Description: SOFTWARE 8263005 ACCUGUIDE MONIT V2.0 CD FDA UDI

Identifiers

Primary DI / UDI-DI: 00613994161635 FDA UDI
510(k) Number: K990793 FDA UDI
FDA Product Code: IKN FDA UDI
GXZ FDA UDI
IKT FDA UDI
GMDN Term: Nerve-locating system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.1375 FDA UDI
882.1350 FDA UDI
890.1385 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Nerve-locating system

Accuguide® by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Nerve-locating system.

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SENTIO — Medos International Sàrl · Class II
Halyard — Avanos Medical, Inc. · Class II
Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
NIM-Eclipse — MEDTRONIC SOFAMOR DANEK, INC. · Class II
AVANOS — Avanos Medical, Inc. · Class II

Cleared under the same submission

K990793 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Medtronic Xomed, Inc.

Sources (1)

FDA UDI 10b21145-dc96-4a30-ac6c-5a14c740d4b5 35 fields · synced Jun 1, 2026