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: NEEDLE 8263210 5PK 30G W/ELECTRODE ROHS FDA UDI
Model / Reference: 8263210 FDA UDI
Description: NEEDLE 8263210 5PK 30G W/ELECTRODE ROHS FDA UDI

Identifiers

Primary DI / UDI-DI: 20643169344994 FDA UDI
510(k) Number: K990793 FDA UDI
FDA Product Code: GXZ FDA UDI
IKN FDA UDI
IKT FDA UDI
GMDN Term: Nerve-locating system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1350 FDA UDI
890.1375 FDA UDI
890.1385 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Dimensions & Sizes

Size: Length — 25.0 Millimeter FDA UDI
Needle Gauge — 30.0 Gauge 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 ead0ebb3-3c69-4c0d-b8f2-7db613c4e9d1 37 fields · synced May 30, 2026