FDA.reportPublic FDA data

PIC INSUPEN ORIGINAL

Primary DI
00812383030846
Brand
PIC INSUPEN ORIGINAL
Company
PIKDARE SPA
Model
02002262030100
Catalog number
02002262030100
Device description
PEN NEEDLE G32x4mm
Published
2023-02-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
50812383030841PackageGS112In Commercial Distribution
00812383030846PrimaryGS10
10812383030843Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5081238303084150812383030841
00812383030846008123830308468123830308460812383030846
1081238303084310812383030843

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

Contacts#

Phone, Email table
PhoneEmail
1-877-660-1900info@htl-strefa.com

Regulatory Flags#

DUNS number
437816603
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
00812383030853DropSafe Sicura02099940180250020999401802502023-07-16
00812383030860DropSafe Sicura02099940210250020999402102502023-07-16
00812383030877DropSafe Sicura02099940220250020999402202502023-07-16
00812383030884DropSafe Sicura02099940230250020999402302502023-07-16
00812383030983DropSafe Sicura02099940250250020999402502502023-07-16
00812383030990DropSafe Sicura02099940250160020999402501602023-07-16
00812383031003DropSafe Sicura02099940270130020999402701302023-07-16
00812383031010DropSafe Sicura02099940300130020999403001302023-07-16
20812383030857DropSafe Sicura02099940180250020999401802502023-07-16
20812383030864DropSafe Sicura02099940210250020999402102502023-07-16
20812383030871DropSafe Sicura02099940220250020999402202502023-07-16
20812383030888DropSafe Sicura02099940230250020999402302502023-07-16
20812383030987DropSafe Sicura02099940250250020999402502502023-07-16
20812383030994DropSafe Sicura02099940250160020999402501602023-07-16
20812383031007DropSafe Sicura02099940270130020999402701302023-07-16
20812383031014DropSafe Sicura02099940300130020999403001302023-07-16
00812383030402PIC INSUPEN02002262000040020022620000402019-07-19
00812383030419PIC INSUPEN02022902000040020229020000402019-07-19
00812383030426PIC INSUPEN02022988000070020229880000702019-07-19
00812383030433PIC INSUPEN02022990000070020229900000702019-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20192253037033MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037040MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037064MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037071MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037088MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037101MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037125MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037132MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037156MonojectCardinal Health 200, LLCFMI2026-07-09
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