FDA.reportPublic FDA data

CAPIJECT SAFETY LANCET

Primary DI
50389701009228
Brand
CAPIJECT SAFETY LANCET
Company
ASAHI POLYSLIDER COMPANY,LIMITED
Model
200104
Device description
Box of 200 Sterile Single-Use Lancing Device Needle 23G
Published
2023-08-01
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

Product Codes#

Code, Name table
CodeName
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50389701009228PackageGS110In Commercial Distribution
30389701009224PrimaryGS10
80812608030305Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5038970100922850389701009228
3038970100922430389701009224
8081260803030580812608030305

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge23Gauge

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
718296825
Device count
200
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30389701009194CAPIJECT SAFETY LANCET2001012023-08-01
30389701009200CAPIJECT SAFETY LANCET2001022023-08-01
30389701009217CAPIJECT SAFETY LANCET2001032023-08-01
30389701009224CAPIJECT SAFETY LANCET2001042023-08-01
30389701009231CAPIJECT SAFETY LANCET2001052023-08-01
80812608030275CAPIJECT SAFETY LANCET2001012023-08-01
50389701009204CAPIJECT SAFETY LANCET2001022023-08-01
50389701009211CAPIJECT SAFETY LANCET2001032023-08-01
50389701009235CAPIJECT SAFETY LANCET2001052023-08-01
04580505780462HemoCue Safety Lancet1301482022-11-30
84580505780659HemoCue Safety Lancet1301482022-11-30
00812608030262OneTouch Delica Safety024-318OTD Safety 30g US 2002022-11-25
20812608030266OneTouch Delica Safety024-318OTD Safety 30g US 2002022-11-25
00812608030026OneTouch Delica Plus Lancet02401101OTDP Lancet 30g 100 US2019-02-28
00812608030033OneTouch Delica Plus Lancet013-026OTDP Lancet Bag 33g US/CA2022-01-31
00812608030040OneTouch Delica Plus Lancet013-027OTDP Lancet Bag 30g US/CA2021-12-06
00812608030057OneTouch Delica Plus Lancing Device02397301OTDP Lancing Device US2019-02-28
00812608030217OneTouch Delica Plus Lancet02419901OTDP Lancet 30g 30 US2020-11-18
00812608030149OneTouch Delica Plus Lancet02419901OTDP Lancet 30g 30 US2020-11-18
00812608030019OneTouch Delica Plus Lancet02400801OTDP Lancet 33g 100 US2019-02-28

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