FDA.report

Ultilet 30g Classic Twist Lancet

Primary DI
10743820301014
Brand
Ultilet 30g Classic Twist Lancet
Company
Boca Med, LLC
Model
30101
Device description
Ultilet 30g TwistTop Blood Lancet NDC Number: 08326-3010-01
Published
2023-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
QRLMultiple Use Blood Lancet For Single Patient Use Only

Product Code Classifications

CodeDeviceSpecialtyClass
QRLMultiple Use Blood Lancet For Single Patient Use OnlyGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20743820301011PackageGS120In Commercial Distribution
30743820301018PackageGS110In Commercial Distribution
10743820301014PrimaryGS10
00743820301017Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2074382030101120743820301011
3074382030101830743820301018
1074382030101410743820301014
00743820301017007438203010177438203010170743820301017

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
121164730
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
20743820212256Ultilet Safety Blades 21G x 2.2mm212252023-04-04
10743820232165TestWell Choice 23G Safety Lancet232162023-02-10
00743820000095ULTI-LANCE000092023-02-08
10743820218169TestWell Choice 21G Safety Lancet218162023-02-07

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
36945630142001STERiLANCESterilance Medical (Suzhou) Inc.QRL2026-03-09
00810079240586Teladoc Health, Inc.Teladoc Health, Inc.QRL2026-02-17
20682607541823On Call Stealth Lancing DeviceAcon Laboratories, Inc.QRL2026-02-03
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
06949517009028One +StepShandong Lianfa Medical Plastic Products CO.,LTDQRL2025-09-14
MHC18080020EasyTouchMHC MEDICAL PRODUCTS, LLCQRL2025-08-04
56949517070894One +StepShandong Lianfa Medical Plastic Products CO.,LTDQRL2025-06-27
56949517070900One +StepShandong Lianfa Medical Plastic Products CO.,LTDQRL2025-06-27
56949517070917One +StepShandong Lianfa Medical Plastic Products CO.,LTDQRL2025-06-27
06949517008878One +StepShandong Lianfa Medical Plastic Products CO.,LTDQRL2025-06-27
00311917069227WalgreensWALGREEN CO.QRL2025-06-20
00810011730601SinocareTianjin Huahong Technology Co., Ltd.QRL2025-06-19
10673486002478GLUCOPAD TC-SMART+ Lancets KitTECO DIAGNOSTICSQRL2025-06-10
26945630136669sutter syncSterilance Medical (Suzhou) Inc.QRL2025-05-23
10673486002461GLUCOPAD TC-SMART+ Lancets KitTECO DIAGNOSTICSQRL2025-05-14
30810011730336Care TouchTianjin Huahong Technology Co., Ltd.QRL2025-04-23
50810011730590LinkSunTianjin Huahong Technology Co., Ltd.QRL2025-04-23
36945630136178TRANSTEKSterilance Medical (Suzhou) Inc.QRL2025-04-22
26945630136164TRANSTEKSterilance Medical (Suzhou) Inc.QRL2025-04-22
10875011000120Greater Goods Greater GoodsQRL2025-04-20
00840423500516VivaGuard Lancets (21G)ABOUND Diagnostics, Inc.QRL2025-04-11
00840423500103VivaGuard Lancets (28G)ABOUND Diagnostics, Inc.QRL2025-04-11
00840423500424VivaGuard Lancing Device ABOUND Diagnostics, Inc.QRL2025-04-11
16971292003516AUVONShenzhen Yuwen E-Commerce Co., Ltd.QRL2025-04-10
16971292003523AUVONShenzhen Yuwen E-Commerce Co., Ltd.QRL2025-04-10
16971292003509AUVONShenzhen Yuwen E-Commerce Co., Ltd.QRL2025-04-09