FDA.reportPublic FDA data

OsteoJ

Primary DI
08052440105168
Brand
OsteoJ
Company
MDL SRL
Model
PJ1115
Catalog number
PJ1115
Device description
DISPOSABLE BONE MARROW BIOPSY NEEDLE WITH EXTRACTION WIRE AND SAFETY 11Gx150mm
Published
2018-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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
08052440105168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052440105168080524401051688052440105168

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
447228586
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056138586109PaliumPLPL2021-05-17
18056138586243MarkPN2015PN20152021-05-17
18056138586250AutoMarkPNA2005PNA20052021-05-17
18056138586267AutoMarkPNA2010PNA20102021-05-17
18056138586274AutoMarkPNA2015PNA20152021-05-17
18056138586304MarkSlimPNS2010PNS20102021-05-17
18056138586311MarkslimPNS2015PNS20152021-05-17
08056138586352RepoMarkPR2005PR20052021-05-17
18056138586366RepoMarkPR2007PR20072021-05-17
18056138586373RepoMarkPR2010PR20102021-05-17
18056138586380RepoMarkPR2015PR20152021-05-17
18056138586397PressToPS0810PS08102021-05-17
18056138586403PressToPS1110PS11102021-05-17
18056138586410PressToPS1115PS11152021-05-17
18056138586427PressToPS1306PS13062021-05-17
18056138586434PressToPS1310PS13102021-05-17
28056138586615ThemyTY1206TY12062021-05-17
28056138586622ThemyTY1209TY12092021-05-17
28056138586639ThemyTY1211TY12112021-05-17
28056138586646ThemyTY1410TY14102021-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450681203Preston™Merit Medical Systems, Inc.DWO2026-02-03
04046964993312AESCULAPAESCULAP, INC.DWO2026-01-16
04046964993329AESCULAPAESCULAP, INC.DWO2026-01-16
08057276004814Cell-HarvestORM.D.L. S.R.L.DWO2025-04-29
08057276004821Bone-HarvestORM.D.L. S.R.L.DWO2025-04-29
G6352120052MAMAWIREHISTO S.A.DWO2024-05-17
G6352120072MAMAWIREHISTO S.A.DWO2024-05-17
G6352120102MAMAWIREHISTO S.A.DWO2024-05-17
G6352120122MAMAWIREHISTO S.A.DWO2024-05-17
G6352120132MAMAWIREHISTO S.A.DWO2024-05-17
G6352120152MAMAWIREHISTO S.A.DWO2024-05-17
G6353120052MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G6353120072MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G6353120102MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G6353120122MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G6353120132MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G6353120152MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G635360015DANA 2.2 MG GHISTO S.A.DWO2024-05-17
G635360015G1DANA 2.2 MG GHISTO S.A.DWO2024-05-17
G6358120202BLO-KHISTO S.A.DWO2024-05-17
G6358120252BLO-KHISTO S.A.DWO2024-05-17
G6359118102MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810B2MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810D2MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810DB2MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810DY2MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G6355512102BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551210C2BIOCORE II MGHISTO S.A.DWO2024-05-16
G6355512132BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551213C2BIOCORE II MGHISTO S.A.DWO2024-05-16