FDA.reportPublic FDA data

1st Tier Unilet

Primary DI
00761059565000
Brand
1st Tier Unilet
Company
OWEN MUMFORD USA INCORPORATED
Model
AT 0565FT
Device description
1st Tier Unilet lancets 28G
Published
2023-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00761059565369PrimaryGS10
00761059565000Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00761059565369007610595653697610595653690761059565369
00761059565000007610595650007610595650000761059565000

GMDN Terms#

Term, Definition table
TermDefinition
Blood lancing device tipA sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge28Gauge

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
803401454
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00384701604010Unistik Pro PlusAT 16042025-09-16
00384703160019EmpelvicSM 31602025-08-22
00384703150010EmpelvicSM 31502025-08-22
00384703155015EmpelvicSM 31552025-08-22
00761059640004Unifine OTCAN 36402025-02-14
00761059641001Unifine OTCAN 36412025-02-14
00761059650003Unifine OTCAN 36502025-02-14
00761059651000Unifine OTCAN 36512025-02-14
00761059640028Unifine OTCAN 36402025-02-14
00761059641032Unifine OTCAN 36412025-02-14
00761059650027Unifine OTCAN 36502025-02-14
00761059651031Unifine OTCAN 36512025-02-14
00761059507093Unifine PentipsAN 3550AC2024-05-17
00761059359012Unifine PentipsAN 3590AC2024-02-21
00761059354000Unifine PentipsAN 3540AC2024-02-05
00761059354024Unifine PentipsAN 3540AC2024-02-05
00761059352914Unifine PentipsAN 3529AC2024-01-22
00761059352921Unifine PentipsAN 3529AC2024-01-22
00384707001011Unistik VacuFlipBC 70012023-10-06
00384707102015Unistik VacuFlipBC 71022023-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015786890True IntegralTRUE INTEGRAL INCQRK2026-05-28
00860015970701True IntegralTRUE INTEGRAL INCQRK2026-05-27
00860015786838True IntegralTRUE INTEGRAL INCQRK2026-05-20
00810011730694GoodLifeTianjin Huahong Technology Co., Ltd.QRK2026-05-09
00850080988428AUVONUAN HEALTHCARE LIMITEDQRK2026-05-09
00810011730687GoodLifeTianjin Huahong Technology Co., Ltd.QRK2026-05-06
00860015383969True IntegralTRUE INTEGRAL INCQRK2026-04-14
00682607541072On Call Lancets (33G)Acon Laboratories, Inc.QRK2026-03-30
00301936020217MICROLET® NEXTASCENSIA DIABETES CARE US INC.QRK2026-03-16
00301936021214MICROLET® NEXTASCENSIA DIABETES CARE US INC.QRK2026-03-16
16945630142014STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142021STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142038STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142045STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142069STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
00197344174433CARINGMEDLINE INDUSTRIES, INC.QRK2026-03-03
00850080988107AUVONUAN HEALTHCARE LIMITEDQRK2026-03-02
00850080988114AUVONUAN HEALTHCARE LIMITEDQRK2026-03-02
00682607541058On Call Lancets 30GAcon Laboratories, Inc.QRK2026-02-19
00810079240586Teladoc Health, Inc.Teladoc Health, Inc.QRK2026-02-17
00810079240609Teladoc Health, Inc.Teladoc Health, Inc.QRK2026-02-17
00850080988091AUVONUAN HEALTHCARE LIMITEDQRK2026-02-06
16945630141291STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-01-02
16945630141307SinocareSterilance Medical (Suzhou) Inc.QRK2026-01-02
16945630141284STERiLANCESterilance Medical (Suzhou) Inc.QRK2025-12-31
00810011730649HuahongTianjin Huahong Technology Co., Ltd.QRK2025-12-24
MHC1826101EasyTouchMHC MEDICAL PRODUCTS, LLCQRK2025-11-10
20197344111838MEDLINEMEDLINE INDUSTRIES, INC.QRK2025-10-22
00383568101137EasyLife Blood Lancet 30G 100pcsCare Living Diagnostics Inc.QRK2025-09-17
00383568101144EasyLife Blood Lancet 31G 100pcsCare Living Diagnostics Inc.QRK2025-09-17