FDA.report

Cell-HarvestOR

Primary DI
08057276004814
Brand
Cell-HarvestOR
Company
M.D.L. S.R.L.
Model
PSH1D21110
Catalog number
PSH1D21110
Device description
MULTIRADIAL SELECTIVE HARVESTING SYSTEM OF AUTOLOGOUS BONE MARROW 11G x 100 mm
Published
2025-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
DWONeedle, Biopsy, Cardiovascular

Product Code Classifications

CodeDeviceSpecialtyClass
DWONeedle, Biopsy, CardiovascularGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08057276004814PrimaryGS10

GMDN Terms

TermDefinition
Bone marrow explant needleA sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously explant bone marrow (explant is the collection and transfer of living bone marrow from its natural site to a new site, or to a culture medium). The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the sternum, hip bone, or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. This is a single-use device.

Sterilization Methods

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 DIBrandModelCatalogPublished
08057276004821Bone-HarvestORPS0810PS08102025-04-29
08056138586338MarkXPNX2010PNX20102025-02-28
08057276004715MarkXPNX2015PNX20152025-02-28
28056138586721ThemyTY1810TY18102021-05-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10884450681203Preston™Merit Medical Systems, Inc.DWO2026-02-03
04046964993312AESCULAPAESCULAP, INC.DWO2026-01-16
04046964993329AESCULAPAESCULAP, INC.DWO2026-01-16
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
G6355512152BIOCORE II MGHISTO S.A.DWO2024-05-16