FDA.reportPublic FDA data

On Call Stealth Lancing Device

Primary DI
20682607541823
Brand
On Call Stealth Lancing Device
Company
Acon Laboratories, Inc.
Model
G124-18A
Catalog number
G124-18A
Device description
1 Lancing Device
Published
2026-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
QRLMultiple use blood lancet for single patient use only

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QRLMultiple Use Blood Lancet For Single Patient Use OnlyGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113332000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113332000ON CALL CHOSEN LANCING DEVICEACON Laboratories, Inc.2012-04-18FMK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20682607541823PackageGS1100In Commercial Distribution
00682607541829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2068260754182320682607541823
00682607541829006826075418296826075418290682607541829

GMDN Terms#

Term, Definition table
TermDefinition
Manual blood lancing device, reusableA hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable 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 reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)838-9502support@aconlabs.com

Regulatory Flags#

DUNS number
781100966
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
false
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
00682607541072On Call Lancets (33G)G124-10AG124-10A2026-03-30
00682607541065On Call Lancing DeviceG124-11AG124-11A2026-03-18
00682607690053Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TC131-2041C131-20412026-03-09
00682607690077Mission Cholesterol Optical Check DeviceC121-2021C121-20212026-03-09
00682607690084Mission Cholesterol Control SolutionC121-2011C121-20112026-03-09
00682607690091Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TC131-2041C131-20412026-03-09
10682607690050Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TC131-2041C131-20412026-03-09
00682607690060Mission Cholesterol MeterC111-2021C111-20212026-03-09
10682607690074Mission Cholesterol Optical Check DeviceC121-2021C121-20212026-03-09
10682607690081Mission Cholesterol Control SolutionC121-2011C121-20112026-03-09
10682607690098Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TC131-2041C131-20412026-03-09
00682607541058On Call Lancets 30GG124-10AG124-10A2026-02-19
10682607541055On Call Lancets 30GG124-10AG124-10A2026-02-19
20682607200485Mission U120 Smart Urine AnalyzerU117-1012026-02-06
20682607200492Mission U120 Smart Urine AnalyzerU117-1112026-02-06
20682607200904Mission U120 Touch Urine AnalyzerU119-106-1012026-02-06
20682607200911Mission U120 Touch Urine AnalyzerU119-116-1012026-02-06
00682607541829On Call Stealth Lancing DeviceG124-18AG124-18A2026-02-03
00810107290002Flowflex Plus COVID-19 + Flu A/B Home TestL03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945L03A-R0645, L03A-R0745, L03A-R0845, L03A-R09452026-01-30
00810107290033Flowflex Plus COVID-19 + Flu A/B Home TestL03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945L03A-R0645, L03A-R0745, L03A-R0845, L03A-R09452026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00810011730700GoodLifeTianjin Huahong Technology Co., Ltd.QRL2026-05-11
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00810011730687GoodLifeTianjin Huahong Technology Co., Ltd.QRL2026-05-06
00860015383952True IntegralTRUE INTEGRAL INCQRL2026-04-14
16945630142007STERiLANCESterilance Medical (Suzhou) Inc.QRL2026-03-09
36945630142001STERiLANCESterilance Medical (Suzhou) Inc.QRL2026-03-09
00850080988107AUVONUAN HEALTHCARE LIMITEDQRL2026-03-02
00850080988114AUVONUAN HEALTHCARE LIMITEDQRL2026-03-02
00810079240579Teladoc Health, Inc.Teladoc Health, Inc.QRL2026-02-17
00810079240586Teladoc Health, Inc.Teladoc Health, Inc.QRL2026-02-17
00850080988091AUVONUAN HEALTHCARE LIMITEDQRL2026-02-06
00682607541829On Call Stealth Lancing DeviceAcon Laboratories, Inc.QRL2026-02-03
00810011730649HuahongTianjin Huahong Technology Co., Ltd.QRL2025-12-24
50810011730644HuahongTianjin Huahong Technology Co., Ltd.QRL2025-12-24
00810011730656HuahongTianjin Huahong Technology Co., Ltd.QRL2025-12-24
00810011730663AllevyTianjin Huahong Technology Co., Ltd.QRL2025-12-24
06949517009462N/MShandong Lianfa Medical Plastic Products CO.,LTDQRL2025-12-10
00850065253305LIVE TULA Lancing DeviceTULA HEALTH, INC.QRL2025-12-03
MHC1808002EasyTouchMHC MEDICAL PRODUCTS, LLCQRL2025-11-10
00810079240456Teladoc Health, Inc.Teladoc Health, Inc.QRL2025-10-10
00383568101137EasyLife Blood Lancet 30G 100pcsCare Living Diagnostics Inc.QRL2025-09-17
00383568101144EasyLife Blood Lancet 31G 100pcsCare Living Diagnostics Inc.QRL2025-09-17
MHC1708001Members MarkMHC MEDICAL PRODUCTS, LLCQRL2025-09-16
MHC1730101Members MarkMHC MEDICAL PRODUCTS, LLCQRL2025-09-16
MHC1732101Members MarkMHC MEDICAL PRODUCTS, LLCQRL2025-09-16
06949517009028One +StepShandong Lianfa Medical Plastic Products CO.,LTDQRL2025-09-14
MHC18080020EasyTouchMHC MEDICAL PRODUCTS, LLCQRL2025-08-04
06949517008847One +StepShandong Lianfa Medical Plastic Products CO.,LTDQRL2025-06-27
06949517008854One +StepShandong Lianfa Medical Plastic Products CO.,LTDQRL2025-06-27