FDA.reportPublic FDA data

PIC INSUPEN ORIGINAL

Primary DI
50812383030834
Brand
PIC INSUPEN ORIGINAL
Company
PIKDARESOCIETA' PER AZIONI
Model
02022990030100
Catalog number
02022990030100
Device description
PEN NEEDLE G31x8mm
Published
2023-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203792000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203792000Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needlePikdare Spa2023-01-20FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50812383030834PackageGS112In Commercial Distribution
00812383030839PrimaryGS10
10812383030836Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5081238303083450812383030834
00812383030839008123830308398123830308390812383030839
1081238303083610812383030836

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
1-877-660-1900info@htl-strefa.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
50812383030841PIC INSUPEN ORIGINAL02002262030100020022620301002023-02-12
50812383030407PIC INSUPEN02002262000040020022620000402019-07-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16972857299337Pen Needles ClassicSandstone Medical (Suzhou) Inc.FMI2026-10-11
16972857299290Easydrip Readygard DuoSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299306Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299313Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09
00050428167243TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
00050428167267TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
06958697621821One+Step INSULIN PEN NEEDLEANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTDFMI2026-10-01
M99230402912120LCH3Livaclean HealthCarelife (usa) Inc.FMI2026-09-30
M99230403250120LCH3Livaclean HealthCarelife (usa) Inc.FMI2026-09-30
00850002860733Comfort EZ Pro DuoS.D.I. USA, INC.FMI2026-09-28
10192253005059MonojectCardinal Health 200, LLCFMI2026-09-24
10809160538913HalyardMEDICAL ACTION INDUSTRIES INC.FMI2026-09-24
16972857299252Pen NeedlesSandstone Medical (Suzhou) Inc.FMI2026-09-24
MHC18290272EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18310472EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18313672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18320872EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18323672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
00850091070013CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070235CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070242CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070259CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070266CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070273CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070280CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070297CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070303CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070310CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070327CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070334CoreCareCORECARE PRODUCTS INC.FMI2026-09-04