FDA.reportPublic FDA data

Intro

Primary DI
08056138586512
Brand
Intro
Company
M.D.L. S.R.L.
Model
PT15110
Catalog number
PT15110
Device description
COAXIAL INTRODUCER NEEDLE 15G X 110 mm
Published
2021-05-14
Public version status
Update
Distribution status
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
18056138586519PackageGS110In Commercial Distribution
08056138586512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805613858651918056138586519
08056138586512080561385865128056138586512

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
Length110Millimeter
Needle Gauge15Gauge

Regulatory Flags#

DUNS number
447228586
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
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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