FDA.reportPublic FDA data

ProCure

Primary DI
10840330705599
Brand
ProCure
Company
Twin Med, LLC
Model
PCSDPN500
Catalog number
PCSDPN500
Device description
"ProCureSafe Sterile Dual Safety Pen Needles 31g 3/16"" 5mm - 100ea/bx 8bx/cs"
Published
2026-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K253622000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253622000Safety Pen NeedleNingbo Medsun Medical Co., Ltd.2026-03-18FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30840330705593PackageGS18In Commercial Distribution
10840330705599PrimaryGS10
00840330705592Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084033070559330840330705593
1084033070559910840330705599
00840330705592008403307055928403307055920840330705592

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
Needle Gauge31Gauge

Contacts#

Phone, Email table
PhoneEmail
804-776-2873xx@xx.xx

Regulatory Flags#

DUNS number
107071289
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840330706152ProCurePCHCMD44PCHCMD442026-04-08
10840330706169ProCurePCHCMD22PCHCMD222026-04-08
10840330706176ProCurePCHCMDS44PCHCMDS442026-04-08
10840330706183ProCurePCHCMDS22PCHCMDS222026-04-08
10840330700259Procure010-104858010-1048582022-11-02
10840330700266Procure100224810022482022-11-02
10840330700273Procure100228310022832022-11-02
10840330702208ProCurePC650CBPC650CB2026-06-01
10840330702215ProCurePC660CBPC660CB2026-06-01
10840330702222ProCurePC670CBPC670CB2026-06-01
10840330702239ProCurePC680CBPC680CB2026-06-01
10840330702246ProCurePC690CBPC690CB2026-06-01
10840330702024ProCurePC600CBPC600CB2026-05-29
10840330702062ProCurePC610CBPC610CB2026-05-29
10840330702109ProCurePC620CBPC620CB2026-05-29
10840330702147ProCurePC630CBPC630CB2026-05-29
10840330702185ProCurePC640CBPC640CB2026-05-29
10840330702765ProCurePC860PC8602026-07-08
10840330706756ProCurePC600CB-APC600CB-A2026-06-01
10840330706763ProCurePC610CB-APC610CB-A2026-06-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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16972857299252REDOX SMART PAN Pen NeedleSandstone 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
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00850068519385SAM MedicalZien Medical Technologies, LLCFMI2026-09-03
00814965020481Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020504Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020528Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020542Precision PointGold Coast Medical Supply, LPFMI2026-08-26