FDA.reportPublic FDA data

PIC INSUPEN

Primary DI
50812383030407
Brand
PIC INSUPEN
Company
PIKDARESOCIETA' PER AZIONI
Model
02002262000040
Catalog number
02002262000040
Device description
PEN NEEDLE 32GX4MM
Published
2019-07-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051783000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051783000ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLESArtsana S.P.A2005-10-04FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50812383030407PackageGS112In Commercial Distribution
00812383030402PrimaryGS10
90812383030405Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5081238303040750812383030407
00812383030402008123830304028123830304020812383030402
9081238303040590812383030405

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

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
1-866-633-7527CLAIM@PIKDARE.COM

Regulatory Flags#

DUNS number
437816603
Device count
100
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50812383030827PIC INSUPEN ORIGINAL02022902030100020229020301002023-02-12
50812383030834PIC INSUPEN ORIGINAL02022990030100020229900301002023-02-12
50812383030841PIC INSUPEN ORIGINAL02002262030100020022620301002023-02-12
50812383030414PIC INSUPEN02022902000040020229020000402019-07-19
50812383030421PIC INSUPEN02022988000070020229880000702019-07-19
50812383030438PIC INSUPEN02022990000070020229900000702019-07-19
50812383030445PIC INSUPEN02022983000040020229830000402019-07-19
50812383030452PIC INSUPEN02022984000040020229840000402019-07-19
50812383030469PIC INSUPEN02022987000040020229870000402019-07-19
50812383030476PIC INSUPEN02022989000070020229890000702019-07-19
50812383030506PIC INSUPEN02002266010040020022660100402019-07-19
50812383030513PIC INSUPEN02002264000040020022640000402019-07-19
50812383030605DROPLET02022987000100020229870001002019-07-19

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Primary DI, Brand, Company table
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20192253036982MonojectCardinal Health 200, LLCFMI2026-07-09
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20192253038337MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038368MonojectCardinal Health 200, LLCFMI2026-07-09
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