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Biocore Ii

FDA UDI

Class I (US FDA UDI)

by Histo S.a.

Identity

Trade Name
BIOCORE II FDA UDI
Generic Name
Side-notch biopsy gun needle FDA UDI
Device Name
Biocore II Tissue Biopsy Needles FDA UDI
Model / Reference
16 Ga x 20 cm FDA UDI
Description
Biocore II Tissue Biopsy Needles FDA UDI

Identifiers

Catalog Number
441620 FDA UDI
Primary DI / UDI-DI
G635441620 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

Biocore Ii by Histo S.a. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 b5b5b15a-0585-4414-8a6e-ff5b10a196ff 36 fields · synced Jun 8, 2026