Pac

FDA UDI

Class II (US FDA UDI)

by Sterylab Srl

Identity

Trade Name: PAC FDA UDI
Generic Name: Biopsy gun handpiece, mechanical FDA UDI
Device Name: Reusable pistol for cytological aspiration FDA UDI
Model / Reference: PAC FDA UDI
Description: Reusable pistol for cytological aspiration FDA UDI

Identifiers

Catalog Number: PAC102030 FDA UDI
Primary DI / UDI-DI: 08033959221990 FDA UDI
510(k) Number: K051506 FDA UDI
FDA Product Code: FCG FDA UDI
KNW FDA UDI
GMDN Term: Biopsy gun handpiece, mechanical 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

FDA UDI

Single Use

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Biopsy gun handpiece, mechanical

Pac by Sterylab Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Biopsy gun handpiece, mechanical.

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DANA 2.2 MG G — HISTO S.A. · Class I
DANA 2.2 MG G — HISTO S.A. · Class I
PAC-UF — STERYLAB SRL · Class II

Cleared under the same submission

K051506 also covers:

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: Sterylab Srl

Sources (1)

FDA UDI ce20e8f7-78ab-422c-874d-86479919fa8e 35 fields · synced Jun 1, 2026