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Palium

FDA UDI

Class II (US FDA UDI)

by M.d.l. S.r.l.

Identity

Trade Name
Palium FDA UDI
Generic Name
Biopsy gun handpiece, mechanical FDA UDI
Device Name
REUSABLE AUTOMATIC BIOPSY INSTRUMENT FDA UDI
Model / Reference
PL FDA UDI
Description
REUSABLE AUTOMATIC BIOPSY INSTRUMENT FDA UDI

Identifiers

Catalog Number
PL FDA UDI
Primary DI / UDI-DI
08056138586109 FDA UDI
510(k) Number
K160316 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

No

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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Biopsy gun handpiece, mechanical

Palium by M.d.l. S.r.l. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Biopsy gun handpiece, mechanical.

Cleared under the same submission

K160316 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
M.d.l. S.r.l.

Sources (1)

  • FDA UDI 40e67c55-e4a3-475e-a4ef-2a730121fc94 35 fields · synced May 30, 2026