FDA.reportPublic FDA data

Illy

Primary DI
08032986359003
Brand
Illy
Company
M.D.L. S.R.L.
Model
PIL1635/100
Catalog number
PIL1635/100
Device description
"10 CS-DISPOSABLE BONE BIOPSY NEEDLEFOR ILIAC CREST MARROW ASPIRATION,""T"" HANDLE 16G x 35/100 mm"
Published
2017-01-05
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
DWONeedle, Biopsy, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWONeedle, Biopsy, CardiovascularGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08052440100972PackageGS110Not in Commercial Distribution
08032986359003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052440100972080524401009728052440100972
08032986359003080329863590038032986359003

GMDN Terms#

Term, Definition table
TermDefinition
Bone marrow biopsy needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone marrow percutaneously. The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the hip bone or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. The resultant specimen is typically used for the pathological analysis of the source of blood cellular elements. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge16Gauge

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G635212005MAMAWIREHISTO S.A.DWO2024-05-17
G635212007MAMAWIREHISTO S.A.DWO2024-05-17
G635212010MAMAWIREHISTO S.A.DWO2024-05-17
G635212012MAMAWIREHISTO S.A.DWO2024-05-17
G635212013MAMAWIREHISTO S.A.DWO2024-05-17
G635212015MAMAWIREHISTO S.A.DWO2024-05-17
G635312005MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G635312007MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G635312010MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G635312012MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G635312013MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G635312015MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G635812020BLO-KHISTO S.A.DWO2024-05-17
G635812025BLO-KHISTO S.A.DWO2024-05-17
G635911810MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810B1MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810D1MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810DB1MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810DY1MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810Y1MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635551210BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551210C1BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551213BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551213C1BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551215BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551215C1BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551216BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551220BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551220C1BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551410BIOCORE II MGHISTO S.A.DWO2024-05-16