Bone-HarvestOR PS0810

GUDID 08057276004821

AUTOLOGOUS BONE HARVESTING SYSTEM 08G x 100 mm

M.D.L. S.R.L.

Bone marrow biopsy needle, single-use
Primary Device ID08057276004821
NIH Device Record Key42955327-a309-41d6-86a6-5ace7a21a9e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone-HarvestOR
Version Model NumberPS0810
Catalog NumberPS0810
Company DUNS447228586
Company NameM.D.L. S.R.L.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length100 Millimeter
Needle Gauge8 Gauge
Length100 Millimeter
Needle Gauge8 Gauge
Length100 Millimeter
Needle Gauge8 Gauge
Length100 Millimeter
Needle Gauge8 Gauge
Length100 Millimeter
Needle Gauge8 Gauge
Length100 Millimeter
Needle Gauge8 Gauge
Length100 Millimeter
Needle Gauge8 Gauge
Length100 Millimeter
Needle Gauge8 Gauge
Length100 Millimeter
Needle Gauge8 Gauge
Length100 Millimeter
Needle Gauge8 Gauge
Length100 Millimeter
Needle Gauge8 Gauge
Length100 Millimeter
Needle Gauge8 Gauge
Length100 Millimeter
Needle Gauge8 Gauge
Length100 Millimeter
Needle Gauge8 Gauge
Length100 Millimeter
Needle Gauge8 Gauge
Length100 Millimeter
Needle Gauge8 Gauge
Length100 Millimeter
Needle Gauge8 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS108057276004821 [Primary]

FDA Product Code

DWONeedle, Biopsy, Cardiovascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-07
Device Publish Date2025-04-29

Devices Manufactured by M.D.L. S.R.L.

08057276004814 - Cell-HarvestOR2025-05-07 MULTIRADIAL SELECTIVE HARVESTING SYSTEM OF AUTOLOGOUS BONE MARROW 11G x 100 mm
08057276004821 - Bone-HarvestOR2025-05-07AUTOLOGOUS BONE HARVESTING SYSTEM 08G x 100 mm
08057276004821 - Bone-HarvestOR2025-05-07 AUTOLOGOUS BONE HARVESTING SYSTEM 08G x 100 mm
08056138586338 - MarkX2025-03-10 NON-REPOSITIONAL DISPOSABLE NEEDLE 20G x 100 mm FOR MAMMARY NODULE LOCALIZATION, WITH DOUBLE HOOK
08057276004715 - MarkX2025-03-10 NON-REPOSITIONAL DISPOSABLE NEEDLE 20G x 150 mm FOR MAMMARY NODULE LOCALIZATION, WITH DOUBLE HOOK
28056138586721 - Themy2021-06-01 DISPOSABLE AUTOMATIC DEVICE 18G X 100 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm

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