FDA.reportPublic FDA data

ProCure

Primary DI
10840330704868
Brand
ProCure
Company
Twin Med, LLC
Model
PCSS520
Catalog number
PCSS520
Device description
Insulin Safety Syringe 1cc 29g x 1/2" - 100ea/bx 5bx/cs
Published
2026-05-27
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
FMFSyringe, Piston
FMINeedle, Hypodermic, Single Lumen
MEGSyringe, Antistick

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
FMINeedle, Hypodermic, Single LumenGeneral Hospital2
MEGSyringe, AntistickGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103011000ULTICARE SAFETY INSULIN SYRINGEUlti-Med Intl., Inc.2011-02-02MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30840330704862PackageGS1100In Commercial Distribution
50840330704866PackageGS15In Commercial Distribution
10840330704868PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084033070486230840330704862
5084033070486650840330704866
1084033070486810840330704868

GMDN Terms#

Term, Definition table
TermDefinition
Metered-delivery hypodermic syringeA sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Needle Gauge0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry and away from sunlight

Contacts#

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

Regulatory Flags#

DUNS number
107071289
Device count
1
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09347144013062Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144013123Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144010009Metier MedicalMETIER MEDICAL LTDMEG2026-10-17
09347144010030Metier MedicalMETIER MEDICAL LTDMEG2026-10-17
09347144010092Metier MedicalMETIER MEDICAL LTDMEG2026-10-17
09347144010122Metier MedicalMETIER MEDICAL LTDMEG2026-10-17
09347144015004Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016186Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016216Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
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
20612479288496McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
20612479288496McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
20612479288526McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
20612479288526McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
20612479288557McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
20612479288588McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
00050428167243TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
00050428167267TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
10304040193843Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193850Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193867Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193874Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193881Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193898Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194109Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194116Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194208Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05