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NeuroPEN

FDA UDI

Class II (US FDA UDI)

by Medtronic PS Medical

Identity

Trade Name
NeuroPEN FDA UDI
Generic Name
Rigid optical intracranial/spinal endoscope, single-use FDA UDI
Device Name
NEUROPEN 2120-035 15MM 19CM DF FDA UDI
Model / Reference
2120-035 FDA UDI
Description
NEUROPEN 2120-035 15MM 19CM DF FDA UDI

Identifiers

Primary DI / UDI-DI
00613994908490 FDA UDI
510(k) Number
K003914 FDA UDI
FDA Product Code
GWG FDA UDI
GMDN Term
Rigid optical intracranial/spinal endoscope, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1480 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 19.0 Centimeter FDA UDI

Category: Rigid optical intracranial/spinal endoscope, single-use

NeuroPEN by Medtronic PS Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid optical intracranial/spinal endoscope, single-use.

Cleared under the same submission

K003914 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic PS Medical

Sources (1)

  • FDA UDI 7aa9efa2-a03a-4acc-9e69-07fccc4d4f4c 37 fields · synced May 30, 2026