FDA.reportPublic FDA data

Intro

Primary DI
08052440106363
Brand
Intro
Company
M.D.L. S.R.L.
Model
PT1705
Catalog number
PT1705
Device description
COAXIAL INTRODUCER NEEDLE17G X 50mm
Published
2017-03-14
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
08058341216682PackageGS110Not in Commercial Distribution
08052440106363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058341216682080583412166828058341216682
08052440106363080524401063638052440106363

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic coaxial injection applicatorA tubular device with a concentric dual-lumen and a plunger intended to be used during surgery for the percutaneous injection of therapeutic materials (e.g., biologics, bone void fillers, irrigation fluids) into a bone, having been passed over a guidewire to the injection site. Typically, the inner lumen is used for the guidewire and the outer lumen for injection of fluids aided by the plunger. The device is made of metal and/or polymer materials. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length50Millimeter
Needle Gauge17Gauge

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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Primary DI, Brand, Company table
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