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NICO BrainPath Approach

FDA UDIEUDAMED

Class I (US FDA UDI)

by NICO Corporation

Identity

Trade Name
NICO BrainPath Approach FDA UDI
Generic Name
Neurosurgical procedure kit, non-medicated, single-use FDA UDI
Device Name
BP & Illumination Pack [13.5x50 mm + PB1113 + SelectLock(G) + meniG + SecureH] + [11GA Illum] FDA UDI
Model / Reference
NN-3007 FDA UDI
Description
BP & Illumination Pack [13.5x50 mm + PB1113 + SelectLock(G) + meniG + SecureH] + [11GA Illum] FDA UDI

Identifiers

Primary DI / UDI-DI
00816744023072 FDA UDI
FDA Product Code
OJG FDA UDI
GMDN Term
Neurosurgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
882.4525 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Neurosurgical procedure kit, non-medicated, single-use

NICO BrainPath Approach by NICO Corporation — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Neurosurgical procedure kit, non-medicated, single-use.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
NICO Corporation

Sources (2)

  • FDA UDI 3cdeff0c-f471-4822-93c9-4cb10950fe11 34 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced May 29, 2026