FDA.reportPublic FDA data

Intro

Primary DI
08052440103522
Brand
Intro
Company
M.D.L. SRL
Model
PT13044
Catalog number
PT13044
Device description
10 CS - COAXIAL INTRODUCER NEEDLE 13G x 44mm
Published
2017-02-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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
08052440103522PackageGS110In Commercial Distribution
08052440103539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052440103522080524401035228052440103522
08052440103539080524401035398052440103539

GMDN Terms#

Term, Definition table
TermDefinition
Nonimplantable needle guide, single-useA rigid, non-powered device designed to lead a needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length44Millimeter
Needle Gauge17Gauge

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
447228586
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
28052440101652ThemyTY1610TY16102020-11-25
08058341212561IntroPT1305PT13052017-02-20
08058341216354IntroPT13075PT130752017-03-14
08052440108978IntroPT15095PT150952017-02-20
08052440108985IntroPT15110PT151102017-02-20
08052440108992IntroPT15140PT151402017-03-14
08058341216682IntroPT1705PT17052017-03-14
08058341211151IntroPT17075PT170752017-01-05
08052440109005IntroPT17095PT170952017-02-20
08052440109029IntroPT17140PT171402017-01-05
08058341219232IntroPT19140PT191402017-01-05
08052440109012IntroPT17110PT171102017-02-20
08052440100750IntroPT17044PT170442017-03-14
08058341219218IntroPT19075PT190752017-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10197106914250CARDINAL HEALTHCardinal Health 200, LLCMJG2025-01-30
10197106905951CARDINAL HEALTHCardinal Health 200, LLCMJG2025-01-17
10197106887622CARDINAL HEALTHCardinal Health 200, LLCMJG2025-01-15