Disposable Brain Biopsy Needle Kit

FDA UDI

Class II (US FDA UDI)

by Ad-Tech Medical Instrument Corp.

Identity

Trade Name: Disposable Brain Biopsy Needle Kit FDA UDI
Generic Name: Brain biopsy procedure kit FDA UDI
Model / Reference: MDBN-08-28X FDA UDI

Identifiers

Catalog Number: MDBN-08-28X FDA UDI
Primary DI / UDI-DI: 00841823106674 FDA UDI
510(k) Number: K112094 FDA UDI
FDA Product Code: FCG FDA UDI
GMDN Term: Brain biopsy procedure kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1075 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

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Brain biopsy procedure kit

Disposable Brain Biopsy Needle Kit by Ad-Tech Medical Instrument Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Brain biopsy procedure kit.

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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: Ad-Tech Medical Instrument Corp.

Sources (1)

FDA UDI 616b3d3f-df5c-4161-9029-0c06429fbb6b 36 fields · synced Jun 9, 2026