FDA.reportPublic FDA data

TRANSTEK

Primary DI
16945630136167
Brand
TRANSTEK
Company
Sterilance Medical (Suzhou) Inc.
Model
"""LDE4 02-2201"""
Published
2025-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26945630136164PackageGS150In Commercial Distribution
36945630136161PackageGS110In Commercial Distribution
16945630136167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2694563013616426945630136164
3694563013616136945630136161
1694563013616716945630136167

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.

Regulatory Flags#

DUNS number
554434897
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16945630137799STERiLANCE"""SteriHeel 2 0.65mm×1.4mm"""2026-04-19
16945630137805STERiLANCE"""SteriHeel 2 0.85mm×1.75mm"""2026-04-19
16945630137812STERiLANCE"""SteriHeel 2 1.0mm×2.5mm"""2026-04-19
16945630137829STERiLANCE"""SteriHeel 2 2.0mm×3.0mm"""2026-04-19
16945630142724STERiLANCESoft 32G2026-03-31
16945630141987STERiLANCEElite 30G 1.8mm2026-03-09
16945630141994STERiLANCE Press2 26G 1.8mm2026-03-09
16945630142007STERiLANCELDE42026-03-09
16945630142014STERiLANCESoft 28G2026-03-09
16945630142021STERiLANCESoft 30G2026-03-09
16945630142038STERiLANCESoft 32G2026-03-09
16945630142045STERiLANCESoft 33G2026-03-09
16945630142069STERiLANCELite3 30G 1.8mm2026-03-09
36945630141981STERiLANCEElite 30G 1.8mm2026-03-09
06945630141997STERiLANCE Press2 26G 1.8mm2026-03-09
36945630142001STERiLANCELDE42026-03-09
36945630142018STERiLANCESoft 28G2026-03-09
36945630142025STERiLANCESoft 30G2026-03-09
36945630142032STERiLANCESoft 32G2026-03-09
36945630142049STERiLANCESoft 33G2026-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810011730700GoodLifeTianjin Huahong Technology Co., Ltd.QRL2026-05-11
00810011730694GoodLifeTianjin Huahong Technology Co., Ltd.QRL2026-05-09
00850080988428AUVONUAN HEALTHCARE LIMITEDQRL2026-05-09
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
20682607541823On 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