FDA.reportPublic FDA data

Palium

Primary DI
08056138586109
Brand
Palium
Company
M.D.L. S.R.L.
Model
PL
Catalog number
PL
Device description
REUSABLE AUTOMATIC BIOPSY INSTRUMENT
Published
2021-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FCGBiopsy Needle
KNWInstrument, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCGBiopsy NeedleGastroenterology, Urology2
KNWInstrument, BiopsyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160316000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160316000SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer NeedlesM.D.L. S.R.L.2016-10-27KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056138586109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056138586109080561385861098056138586109

GMDN Terms#

Term, Definition table
TermDefinition
Biopsy gun handpieceA hand-operated, non-electronic, surgical instrument designed to be used with a dedicated disposable biopsy gun needle (not included) for the automatic extraction of a soft-tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It has a spring-loaded mechanism with a release trigger intended to accept and operate the cutting mechanism of a percutaneous biopsy needle. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
447228586
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08032986359416AutoMarkPNA2005PNA20052017-01-05
08032986359447AutoMarkPNAX2005PNAX20052017-01-05
08032986359867RepoMarkPR2005PR20052017-01-05
08052440107407MarkPNX2007PNX20072017-06-05
08052440107445MarkPNX2010PNX20102017-02-21
08052440107469MarkPN2012PN20122017-03-23
08052440107759AutoMarkPNAX2010PNAX20102017-06-05
08052440107841RepoMarkPR2007PR20072017-01-05
08052440107858RepoMarkPR2010PR20102017-06-05
08056138586222MarkPN2010PN20102021-05-14
08056138586239MarkPN2012PN20122021-05-14
08056138586246MarkPN2015PN20152021-05-17
08056138586253AutoMarkPNA2005PNA20052021-05-17
08056138586260AutoMarkPNA2010PNA20102021-05-17
08056138586277AutoMarkPNA2015PNA20152021-05-17
08056138586307MarkSlimPNS2010PNS20102021-05-17
08056138586314MarkslimPNS2015PNS20152021-05-17
08056138586369RepoMarkPR2007PR20072021-05-17
08056138586376RepoMarkPR2010PR20102021-05-17
08056138586383RepoMarkPR2015PR20152021-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
17340179900122EndoDrill Drive System USBibbinstruments ABFCG2026-10-15
00817295020589InradInradKNW2026-10-09
00817295021081InradInradKNW2026-10-08
00817295021081InradInradFCG2026-10-08
00817295021098InradInradKNW2026-10-08
00817295021098InradInradFCG2026-10-08
00817295021104InradInradKNW2026-10-08
00817295021104InradInradFCG2026-10-08
00817295021111InradInradKNW2026-10-08
00817295021111InradInradFCG2026-10-08
00817295021128InradInradKNW2026-10-08
00817295021128InradInradFCG2026-10-08
00817295021135InradInradFCG2026-10-08
00817295021135InradInradKNW2026-10-08
00817295021142InradInradFCG2026-10-08
00817295021142InradInradKNW2026-10-08
00817295021159InradInradFCG2026-10-08
00817295021159InradInradKNW2026-10-08
00817295021357InradInradKNW2026-10-08
00817295021357InradInradFCG2026-10-08
00817295021364InradInradFCG2026-10-08
00817295021364InradInradKNW2026-10-08
00817295021371InradInradKNW2026-10-08
00817295021371InradInradFCG2026-10-08
00817295021388InradInradFCG2026-10-08
00817295021388InradInradKNW2026-10-08
08055002906272COXMEDAX SRL UNIPERSONALEKNW2026-10-07
10884521833098SharkCoreCovidien LPFCG2026-10-01
10884450831547Tru-Cut®Merit Medical Systems, Inc.KNW2026-09-29
00888867543904Arthrex®ARTHREX, INC.KNW2026-09-25