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BioPince Ultra Full Core Biopsy Instrument

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 360-1580-02

by Argon Medical Devices, Inc.

Identity

Trade Name
BioPince EUDAMED
BioPince Ultra Full Core Biopsy Instrument FDA UDI
Generic Name
End-cut biopsy gun handpiece/needle FDA UDI
Device Name
BioPince Ultra Full Core Biopsy Instrument EUDAMED
BioPince™ Ultra Full Core Biopsy Instrument 18ga x 15cm FDA UDI
Model / Reference
360-1580-02 EUDAMEDFDA UDI
Description
BioPince™ Ultra Full Core Biopsy Instrument 18ga x 15cm FDA UDI

Identifiers

Catalog Number
360-1580-02 FDA UDI
Primary DI / UDI-DI
20886333224023 EUDAMED
00886333224029 FDA UDI
Basic UDI-DI
B-20886333224023 EUDAMED
510(k) Number
K904987 FDA UDI
FDA Product Code
KNW FDA UDI
EMDN Code
A01020199 NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER EUDAMED
GMDN Term
End-cut biopsy gun handpiece/needle FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
876.1075 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

BioPince Ultra Full Core Biopsy Instrument by Argon Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Cleared under the same submission

K904987 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Argon Medical Devices, Inc.

Sources (2)

  • FDA UDI a767a22c-84be-44fb-bea5-47ffa10d6fdc 38 fields · synced Oct 6, 2026
  • EUDAMED 16a8bb6e-7afd-4f11-af13-4175e5a96e51 61 fields · synced Aug 2, 2026