FDA.reportPublic FDA data

Manual blood lancing device, single-use

Definition
A 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.
GUDID devices
837
Last updated
2026-06-05 06:05:29

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00616784711522PA SensiLance Pressure Activated Safety Lancets,SterileDynarex Corporation71152021-05-21
00011822463300TRUEplusTRIVIDIA HEALTH, INC.Rite Aid TRUEplus Safety Lancets2020-10-23
00015482980085Assure® Lance Safety LancetsARKRAY USA, INC.9800282020-03-27
00015482980122Assure® Lance Safety LancetsARKRAY USA, INC.9801252018-09-24
00015482980184Assure® Lance Safety LancetsARKRAY USA, INC.9801282018-09-24
00015482980221Assure® Lance Safety LancetsARKRAY USA, INC.9802252018-09-24
00015482980283Assure® Lance Safety Lancets ARKRAY USA, INC.9802282018-09-24
00015482981211Assure® Lance Safety LancetsARKRAY USA, INC.9801212018-09-24
00015482983284Assure® Lance Safety LancetsARKRAY USA, INC.9803282019-11-25
00015482991258Assure® Lance Plus Safety LancetsARKRAY USA, INC.9901252018-09-24
00015482991302Assure® Lance Plus Safety LancetsARKRAY USA, INC.9901302018-09-24
00021292010522TRUEplusTRIVIDIA HEALTH, INC.TRUEplus Safety Lancets2020-10-23
00021292010539TRUEplusTRIVIDIA HEALTH, INC.TRUEplus Safety Lancets2020-10-23
00050428167274CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDCVS739091V22026-04-09
00093351015328Discount Drug Mart DISCOUNT DRUG MART, INC.AT 1028DDM2023-02-27
00096295117080LEADERCardinal Health 110, Inc.42144092019-06-28
00197344174433CARINGMEDLINE INDUSTRIES, INC.CAR1000302026-03-03
00353885006828One Touch SureSoft LifeScan Europe GmbH021-1392020-02-03
00353885006835One Touch SureSoft LifeScan Europe GmbH021-1402020-02-03
00353885006842OneTouch SureSoftLifeScan Europe GmbH021-1412020-02-03
00357599833008AbbottABBOTT DIABETES CARE INC786322023-01-20
00373317624512AUMSlv Pharmaceuticals LLCSAFETY PEN NEEDLES 32G -4MM2022-03-08
00383568100208CareLiving Pressure Activated Safety lancet 21GCare Living Diagnostics Inc.Activated Safety Lancet 212024-06-21
00383568100215CareLiving Safety lancet 28GCare Living Diagnostics Inc.Safety Lancet 282023-11-10
00383568100246CareLiving Pressure Activated Safety lancet 26GCare Living Diagnostics Inc.Activated Safety Lancet 262024-06-26
00383568200229EasyLife Pressure Activated Safety lancet 28GCare Living Diagnostics Inc.Activated Safety Lancet 28G2025-09-17
00383568200236EasyLife Pressure Activated Safety lancet 30GCare Living Diagnostics Inc.Activated Safety Lancet 30G2025-09-17
00384700702014UnistikOWEN MUMFORD LIMITEDAT 07022020-04-16
00384700704018UnistikOWEN MUMFORD LIMITEDAT 07042020-04-16
00384700712013Unistik OWEN MUMFORD LIMITEDAT 07122020-04-16
00384700714017Unistik OWEN MUMFORD LIMITEDAT 07142020-04-16
00384700747015Unistik OWEN MUMFORD LIMITEDAT 07472020-04-16
00384700752019Unistik 2 Safety Lancets - Super 18GOWEN MUMFORD LIMITEDAT 07522020-04-16
00384701002014Unistik 3OWEN MUMFORD LIMITEDAT 10022019-09-12
00384701004018Unistik 3OWEN MUMFORD LIMITEDAT 10042019-09-19
00384701007019Unistik 3 OWEN MUMFORD LIMITEDAT 10072019-09-19
00384701008016Unistik 3 OWEN MUMFORD LIMITEDAT 10082019-09-19
00384701012013Unistik 3 OWEN MUMFORD LIMITEDAT 10122019-09-12
00384701014017Unistik 3 OWEN MUMFORD LIMITEDAT10142019-09-12
00384701015014Unistik OWEN MUMFORD LIMITEDAT 10152023-02-07
00384701018015Unistik 3 OWEN MUMFORD LIMITEDAT 10182019-09-12
00384701022012Unistik 3 OWEN MUMFORD LIMITEDAT 10222019-09-12
00384701024016Unistik 3 OWEN MUMFORD LIMITEDAT 10242019-09-12
00384701027017Unistik 3OWEN MUMFORD LIMITEDAT 10272023-02-07
00384701028014Unistik 3OWEN MUMFORD USA INCORPORATEDAT 10282022-10-18
00384701042010Unistik 3 - Comfort 28GOWEN MUMFORD LIMITEDAT 10422019-09-12
00384701044014Unistik 3OWEN MUMFORD LIMITEDAT 10442019-09-12
00384701047015Unistik 3 OWEN MUMFORD LIMITEDAT10472019-09-12
00384701048012Unistik 3 OWEN MUMFORD LIMITEDAT10482019-09-12
00384701062018Unistik 3 OWEN MUMFORD LIMITEDAT10622019-09-12
00384701064012Unistik 3 OWEN MUMFORD LIMITEDAT10642019-09-12
00384701200014Unistik TinyTouchOWEN MUMFORD USA INCORPORATEDAT 12002023-03-22
00384701210013Unistik TinyTouchOWEN MUMFORD USA INCORPORATEDAT 12102023-03-22
00384701250019Unistik TinyTouchOWEN MUMFORD USA INCORPORATEDAT 12502023-03-22
00384701260018Unistik TinyTouchOWEN MUMFORD USA INCORPORATEDAT 12602023-03-22
00384701267017Unistik TinyTouchOWEN MUMFORD USA INCORPORATEDAT 12672023-03-22
00384701402012Unistik TouchOWEN MUMFORD LIMITEDAT 14022023-03-30
00384701404016Unistik TouchOWEN MUMFORD LIMITEDAT 14042021-04-02
00384701412011Unistik Touch OWEN MUMFORD LIMITEDAT 14122021-04-02
00384701414015Unistik TouchOWEN MUMFORD LIMITEDAT 14142021-04-02
00384701422010Unistik TouchOWEN MUMFORD LIMITEDAT 14222021-03-26
00384701424014Unistik Touch OWEN MUMFORD LIMITEDAT 14242021-03-26
00384701442018Unistik Touch OWEN MUMFORD LIMITEDAT 14422021-03-26
00384701444012Unistik TouchOWEN MUMFORD LIMITEDAT 14442021-04-02
00384701462016Unistik TouchOWEN MUMFORD LIMITEDAT 14622023-01-17
00384701464010Unistik TouchOWEN MUMFORD LIMITEDAT 14642023-01-17
00384701604010Unistik Pro PlusOWEN MUMFORD USA INCORPORATEDAT 16042025-09-16
00384701614019Unistik ProOWEN MUMFORD LIMITEDAT 16142023-02-07
00384701634017Unistik ProOWEN MUMFORD LIMITEDAT 16342023-02-07
00384701644016Unistik ProOWEN MUMFORD LIMITEDAT 16442023-02-07
00384840823419Prodigy Pressure Activated Safety LancetsProdigy Diabetes Care, LLC24-0823412018-08-21
00384849903389Prodigy Pressure Activated Safety LancetsProdigy Diabetes Care, LLC9903382018-08-21
00628465014525AboutTime MPD 21Gx 1.8mm Safety LancetMedical Plastic Devices M.P.D. Inc12020-02-25
00628465014556AboutTime MPD 23G x1.8mm Safety LancetMedical Plastic Devices M.P.D. Inc12020-02-25
00628465014563AboutTime MPD 28G x 1.8mm Safety LancetMedical Plastic Devices M.P.D. Inc12020-02-25
00628465014587AboutTime MPD 30Gx1.8mm Safety LancetMedical Plastic Devices M.P.D. Inc12020-02-25
00709334581215STAT Medical DevicesStat Medical Devices, Inc.Comfort Thins Twist-Off Lancet2023-11-28
00709334761884STAT Medical DevicesStat Medical Devices, Inc.Qwik-Lance Safety Lancet2024-01-04
00709334883883STAT Medical DevicesStat Medical Devices, Inc.Qwik-Lance Safety Lancet2023-11-28
00810008210062ONE-CARE Safety LancetsMediVena, LLC1101 ONE-CARE Safety Lancets 30G x 1.5mm, MicroFlo2025-02-16