FDA.reportPublic FDA data

FastCutS

Primary DI
08032986358013
Brand
FastCutS
Company
M.D.L. S.R.L.
Model
VES1825
Catalog number
VES1825
Device description
DISPOSABLE NEEDLE 18GX250 MMFOR SOFT TISSUE BIOPSY, COMPATIBLEAUTOMATIC STERYLAB FASTGUN ® GUN
Published
2017-03-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MJGDevice, Percutaneous, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJGDevice, Percutaneous, BiopsyGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08058341210604PackageGS110Not in Commercial Distribution
08032986358013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058341210604080583412106048058341210604
08032986358013080329863580138032986358013

GMDN Terms#

Term, Definition table
TermDefinition
End-cut biopsy gun needleAn invasive tubular surgical instrument designed to be connected to a biopsy gun handpiece (not included) for the automatic extraction of a core tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It is an open, cylindrical needle intended to be percutaneously inserted, typically under image guidance, and is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length250Millimeter
Needle Gauge18Gauge

Regulatory Flags#

DUNS number
447228586
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057276004814Cell-HarvestORPSH1D21110PSH1D211102025-04-29
08057276004821Bone-HarvestORPS0810PS08102025-04-29
08056138586338MarkXPNX2010PNX20102025-02-28
08057276004715MarkXPNX2015PNX20152025-02-28
08056138586109PaliumPLPL2021-05-17
08052440107018PaliumPLPL2017-01-05
08032986351427FastCutMMGC1413MGC14132017-02-21
08032986351533FastCutMMGC1825MGC18252017-02-21
08032986351410PALIUM COAXIALMGC1410MGC14102018-06-07
08058341215203PALIUM COAXIALMGC1210MGC12102018-06-07
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

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