FDA.report

ULTI-LANCE

Primary DI
00743820000095
Brand
ULTI-LANCE
Company
Boca Med, LLC
Model
00009
Device description
Ulti-Lance Fingertip Lancing Device NDC number: 08326-0000-09
Published
2023-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
20743820000099PackageGS1100In Commercial Distribution
30743820000096PackageGS14In Commercial Distribution
00743820000095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2074382000009920743820000099
3074382000009630743820000096
00743820000095007438200000957438200000950743820000095

GMDN Terms

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

Regulatory Flags

DUNS number
121164730
Device count
1
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
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 DIBrandModelCatalogPublished
20743820212256Ultilet Safety Blades 21G x 2.2mm212252023-04-04
10743820232165TestWell Choice 23G Safety Lancet232162023-02-10
10743820218169TestWell Choice 21G Safety Lancet218162023-02-07
10743820301014Ultilet 30g Classic Twist Lancet301012023-02-07

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