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Natus

FDA UDI

Class II (US FDA UDI)

by Natus Medical Incorporated

Identity

Trade Name
Natus FDA UDI
Generic Name
Neurosurgical procedure kit, medicated FDA UDI
Device Name
CRANIAL ACCESS KIT FDA UDI
Model / Reference
HITHRZRX FDA UDI
Description
CRANIAL ACCESS KIT FDA UDI

Identifiers

Primary DI / UDI-DI
40382830062334 FDA UDI
FDA Product Code
PVM FDA UDI
PSP FDA UDI
GMDN Term
Neurosurgical procedure kit, medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4100 FDA UDI
882.1620 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

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, medicated

Natus by Natus Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neurosurgical procedure kit, medicated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Natus Medical Incorporated

Sources (1)

  • FDA UDI f805661c-0262-4138-ad81-2c461acc9be3 33 fields · synced May 30, 2026