FDA.reportPublic FDA data

PIC INSUPEN

Primary DI
00815832020009
Brand
PIC INSUPEN
Company
ARTSANA SPA
Model
00002264000040
Catalog number
00002264000040
Device description
"PEN NEEDLE 33GX5/32""0,20X4MM"
Published
2016-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50815832020004PackageGS112In Commercial Distribution
00815832020009PrimaryGS10
90815832020002Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5081583202000450815832020004
00815832020009008158320200098158320200090815832020009
9081583202000290815832020002

GMDN Terms#

Term, Definition table
TermDefinition
Autoinjector needleA device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-847-682-0224CLAIM@ARTSANA.COM

Regulatory Flags#

DUNS number
428067896
Device count
100
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815832020108PIC INSUPEN00002266010040000022660100402018-04-23
50815832020103PIC INSUPEN00002266010040000022660100402018-04-23
00815832020016PIC INSUPEN00002262000040000022620000402016-10-05
00815832020023PIC INSUPEN00022983000040000229830000402016-10-05
00815832020030PIC INSUPEN 00022984000040 000229840000402016-10-05
00815832020047PIC INSUPEN00022902000040000229020000402016-10-05
00815832020054PIC INSUPEN00022989000070000229890000702016-10-05
00815832020061PIC INSUPEN00022990000070000229900000702016-10-05
00815832020078PIC INSUPEN00022987000040000229870000402016-10-05
00815832020085PIC INSUPEN00022988000070000229880000702016-10-05
50815832020011PIC INSUPEN00002262000040000022620000402016-10-05
50815832020028PIC INSUPEN00022983000040000229830000402016-10-05
50815832020035PIC INSUPEN 00022984000040 000229840000402016-10-05
50815832020042PIC INSUPEN00022902000040000229020000402016-10-05
50815832020059PIC INSUPEN00022989000070000229890000702016-10-05
50815832020066PIC INSUPEN00022990000070000229900000702016-10-05
50815832020073PIC INSUPEN00022987000040000229870000402016-10-05
50815832020080PIC INSUPEN00022988000070000229880000702016-10-05

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Primary DI, Brand, Company table
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