FDA.reportPublic FDA data

HandCut

Primary DI
08052440105687
Brand
HandCut
Company
M.D.L. S.R.L.
Model
PM1610
Catalog number
PM1610
Device description
DISPOSABLE NEEDLE FOR SOFT TISSUE BIOPSY WITH MANUAL ACTION 16G x 100 mm
Published
2021-04-26
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
08052440105687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052440105687080524401056878052440105687

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue biopsy procedure kit, non-medicatedA collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. 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
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
08056138586239MarkPN2012PN20122021-05-14
08056138586246MarkPN2015PN20152021-05-17
08056138586253AutoMarkPNA2005PNA20052021-05-17
08056138586260AutoMarkPNA2010PNA20102021-05-17
08056138586277AutoMarkPNA2015PNA20152021-05-17
08056138586307MarkSlimPNS2010PNS20102021-05-17
08056138586314MarkslimPNS2015PNS20152021-05-17
08056138586369RepoMarkPR2007PR20072021-05-17
08056138586376RepoMarkPR2010PR20102021-05-17
08056138586383RepoMarkPR2015PR20152021-05-17

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Primary DI, Brand, Company table
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