FDA.report

Bone-HarvestOR

Primary DI
08057276004821
Brand
Bone-HarvestOR
Company
M.D.L. S.R.L.
Model
PS0810
Catalog number
PS0810
Device description
AUTOLOGOUS BONE HARVESTING SYSTEM 08G 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
08057276004821PrimaryGS10

GMDN Terms

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

TypeValueUnit
Length100Millimeter
Needle Gauge8Gauge

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
08057276004814Cell-HarvestORPSH1D21110PSH1D211102025-04-29
08056138586338MarkXPNX2010PNX20102025-02-28
08057276004715MarkXPNX2015PNX20152025-02-28
28056138586721ThemyTY1810TY18102021-05-24

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