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Maxicore-M Automatic Biopsy Gun Needle

FDA UDI

Class II (US FDA UDI)

by Geotek Medikal Ve Saglik Hizmetleri Ticaret Sanayi Limited Sirketi

Identity

Trade Name
Maxicore-M Automatic Biopsy Gun Needle FDA UDI
Generic Name
Side-notch biopsy gun needle FDA UDI
Device Name
is a disposable biopsy needle used with reusable biopsy instrument for obtaining histological core samples from soft tissue and organs FDA UDI
Model / Reference
GPN1625-M FDA UDI
Description
is a disposable biopsy needle used with reusable biopsy instrument for obtaining histological core samples from soft tissue and organs FDA UDI

Identifiers

Catalog Number
GPN1625-M FDA UDI
Primary DI / UDI-DI
08681672050443 FDA UDI
FDA Product Code
KNW FDA UDI
GMDN Term
Side-notch biopsy gun needle 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

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Side-notch biopsy gun needle

Maxicore-M Automatic Biopsy Gun Needle by Geotek Medikal Ve Saglik Hizmetleri Ticaret Sanayi Limited Sirketi — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Side-notch biopsy gun needle.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Geotek Medikal Ve Saglik Hizmetleri Ticaret Sanayi Limited Sirketi

Sources (1)

  • FDA UDI a600a55f-c404-4d58-8144-39f8ac305d6d 36 fields · synced May 30, 2026