FDA.reportPublic FDA data

SurgiLance Safety Lancet

Primary DI
58886354702855
Brand
SurgiLance Safety Lancet
Company
MEDIPURPOSE PTE. LTD.
Model
SLN1030
Device description
SurgiLance Safety Lancet, 21G Needle 1.0 mm Yellow, 30/bag, 50 bags/case
Published
2025-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMKLancet, Blood

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222224000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222224000SurgiLance® Safety LancetMedipurpose Pte. , Ltd.2022-09-22FMK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
58886354702855PrimaryGS10
18886354702857Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5888635470285558886354702855
1888635470285718886354702857

GMDN Terms#

Term, Definition table
TermDefinition
Manual blood lancing device, single-useA sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. It includes a preloaded lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
(404) 855-3655sales@medipurpose.com

Regulatory Flags#

DUNS number
628380248
Device count
1500
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
38886354703100SurgiLance Lite Safety LancetSLL25G2202025-05-20
48886354703107SurgiLance Lite Safety LancetSLL25G2202025-05-20
18886354702840SurgiLance Safety LancetSLN304W2025-02-12
28886354703059SurgiLance Safety LancetSLN2422025-02-12
28886354703097SurgiLance Safety LancetSLN2022025-02-12
38886354701861SurgiLance Safety LancetSLN3022025-02-12
38886354701892SurgiLance Safety LancetSLN3042025-02-12
38886354701908SurgiLance Safety LancetSLB2042025-02-12
38886354701915SurgiLance Safety LancetSLB2542025-02-12
38886354702639Anzen Safety ScalpelAZH3L2025-02-12
58886354702640SurgiLance Safety LancetSLN30102025-02-12
58886354702848SurgiLance Safety LancetSLN304W2025-02-12
58886354703050SurgiLance Safety LancetSLN2422025-02-12
58886354703098SurgiLance Safety LancetSLN2022025-02-12
18886354701867SurgiLance Safety LancetSLN3022025-02-12
58886354701896SurgiLance Safety LancetSLN3042025-02-12
58886354701902SurgiLance Safety LancetSLB2042025-02-12
58886354701919SurgiLance Safety LancetSLB2542025-02-12
48886354702636Anzen Safety ScalpelAZH3L2025-02-12
18886354702642SurgiLance Safety LancetSLN30102025-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840330705605ProCureTwin Med, LLCFMK2026-04-22
10840330705612ProCureTwin Med, LLCFMK2026-04-22
10840330705629ProCureTwin Med, LLCFMK2026-04-22
10840330705636ProCureTwin Med, LLCFMK2026-04-22
10840330705643ProCureTwin Med, LLCFMK2026-04-22
10840330705650ProCureTwin Med, LLCFMK2026-04-22
16945630137799STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-04-19
16945630137805STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-04-19
16945630137812STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-04-19
16945630137829STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-04-19
16931918108711AllesetGRI Medical & Electronic Technology Co., Ltd.FMK2026-03-16
16945630141987STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-03-09
16945630141994STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-03-09
08809262393224Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393231Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393248Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393255Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393392Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393408Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393415Sterilized Eol Auto LancetHLB CO.,LTDFMK2025-08-20
08809262393422Sterilized Eol Auto LancetHLB CO.,LTDFMK2025-08-20
08809262393439Sterilized Eol Auto LancetHLB CO.,LTDFMK2025-08-20
08809262393460Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393477Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393484Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
16931918130408Cardinal HealthGRI Medical & Electronic Technology Co., Ltd.FMK2025-06-20
16931918166803Cardinal HealthGRI Medical & Electronic Technology Co., Ltd.FMK2025-06-20
16945630132435STERiLANCE Elite Disposable Safety LancetSterilance Medical (Suzhou) Inc.FMK2024-10-23
16945630132442STERiLANCE Elite Disposable Safety LancetSterilance Medical (Suzhou) Inc.FMK2024-10-23
16945630132466STERiLANCE Elite Disposable Safety LancetSterilance Medical (Suzhou) Inc.FMK2024-10-23