FDA.reportPublic FDA data

EASYLOCK

Primary DI
08032986357498
Brand
EASYLOCK
Company
M.D.L. S.R.L.
Model
PC1910
Catalog number
PC1910
Device description
DISPOSABLE MENGHINI MODIFIED NEEDLEFOR SOFT TISSUE ASPIRATED BIOPSY19G X 100MM
Published
2018-06-07
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
MJGDevice, Percutaneous, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJGDevice, Percutaneous, BiopsyGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08032986357498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08032986357498080329863574988032986357498

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue biopsy needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously obtain a specimen of soft tissue, typically for histopathological examination. The device is usually attached to a syringe for the aspiration of the specimen; it is available in a variety of lengths, diameters (bores), and tip configurations (e.g., straight or curved). This is a single-use device.

Sterilization Methods#

Method table
Method

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

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