FDA.reportPublic FDA data

SurgiLance Safety Lancet

Primary DI
58886354702190
Brand
SurgiLance Safety Lancet
Company
MEDIPURPOSE PTE. LTD.
Model
SLN170S
Device description
SurgiLance Safety Lancet, 28G Needle, 1.7mm, Lime
Published
2017-01-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
K101145000
K222224000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101145000SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250Medipurpose Pte. , Ltd.2010-10-21FMK
K222224000SurgiLance® Safety LancetMedipurpose Pte. , Ltd.2022-09-22FMK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
58886354702190PackageGS115In Commercial Distribution
38886354702196PrimaryGS10
18886354702192Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5888635470219058886354702190
3888635470219638886354702196
1888635470219218886354702192

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
17704489493sales@medipurpose.com
(404) 855-3655sales@medipurpose.com

Regulatory Flags#

DUNS number
628380248
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
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
58886354702855SurgiLance Safety LancetSLN10302025-02-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00050428359112CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFMK2026-06-04
00382830006705NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00382830006712NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00840117346505PA Safety Lancets, Pressure Activated, 21 G NeedleDynarex CorporationFMK2026-06-01
08887629010007SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010106SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010205SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010304SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
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
16931918108711AllesetGRI Medical & Electronic Technology Co., Ltd.FMK2026-03-16
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