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Biocore Ii Mg

FDA UDI

Class I (US FDA UDI)

by Histo S.a.

Identity

Trade Name
BIOCORE II MG FDA UDI
Generic Name
Side-notch biopsy gun needle FDA UDI
Device Name
Biopsy Needle Biocore II MG FDA UDI
Model / Reference
14 Ga x 13 cm FDA UDI
Description
Biopsy Needle Biocore II MG FDA UDI

Identifiers

Catalog Number
551413 FDA UDI
Primary DI / UDI-DI
G635551413 FDA UDI
FDA Product Code
DWO FDA UDI
GMDN Term
Side-notch biopsy gun needle FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

No

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

Yes

FDA UDI

Category: Side-notch biopsy gun needle

The BIOCORE II MG is a medical device used for obtaining tissue samples from anatomical structures, particularly in the kidneys, prostate, pancreas, liver, and breast. It features a side-notch cutter at the distal end of a percutaneously-inserted needle that causes a sharp, sliding cannula to slice a segment of tissue.

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
Histo S.a.

Sources (1)

  • FDA UDI d65b59db-0b74-4f54-88c3-d9f797e3604c 36 fields · synced Jul 15, 2026