FDA.reportPublic FDA data

microdot®

Primary DI
00847713000053
Brand
microdot®
Company
Cambridge Sensors USA LLC
Model
521-21
Device description
21g /2.2mm Pressure Activated Safety Lancet (Box of 200 lancets)
Published
2023-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222376000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222376000Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)Shandong Lianfa Medical Plastic Products Co. , Ltd.2022-10-03FMK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847713000138PackageGS124In Commercial Distribution
00847713000053PrimaryGS10
00847713000312Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847713000138008477130001388477130001380847713000138
00847713000053008477130000538477130000530847713000053
00847713000312008477130003128477130003120847713000312

GMDN Terms#

Term, Definition table
TermDefinition
Blood lancet, single-useA sterile, hand-held, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider to manually puncture the skin of a patient to obtain a small blood specimen or drain a cyst or boil. This is a single-use device.

Regulatory Flags#

DUNS number
962314360
Device count
200
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
00847713001296microdot® Flex1501-102025-12-12
00847713001302microdot® Flex1502-102025-12-12
00847713001319microdot® Flex1503-102025-12-12
00847713001326microdot® Flex1504-102025-12-12
00847713001425microdot® Flex Black1601-102025-12-12
00847713001432microdot® Flex Black1602-102025-12-12
00847713001449microdot® Flex Black1603-102025-12-12
00847713001456microdot® Flex Black1604-102025-12-12
00847713001340microdot® Flex1501-102025-12-12
00847713001258microdot® Flex1502-102025-12-12
00847713001364microdot® Flex1503-102025-12-12
00847713001371microdot® Flex1504-102025-12-12
00847713001463microdot® Flex Black1601-102025-12-12
00847713001470microdot® Flex Black1602-102025-12-12
00847713001487microdot® Flex Black1603-102025-12-12
00847713001494microdot® Flex Black1604-102025-12-12
00847713000930microdot® Pro Gloves1401-102025-02-18
00847713000947microdot® Pro Gloves1402-102025-02-18
00847713000954microdot® Pro Gloves1403-102025-02-18
00847713000961microdot® Pro Gloves1404-102025-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536930407BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
00199536930414BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
00199536930421BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
00050428359112CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFMK2026-06-04
00382830006705NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00382830006712NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00840117346505PA Safety Lancets, Pressure Activated, 21 G NeedleDynarex CorporationFMK2026-06-01
08887629010007SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010106SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010205SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010304SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
10840330705605ProCureTwin Med, LLCFMK2026-04-22
10840330705612ProCureTwin Med, LLCFMK2026-04-22
10840330705629ProCureTwin Med, LLCFMK2026-04-22
10840330705636ProCureTwin Med, LLCFMK2026-04-22
10840330705643ProCureTwin Med, LLCFMK2026-04-22
10840330705650ProCureTwin Med, LLCFMK2026-04-22
16931918108711AllesetGRI Medical & Electronic Technology Co., Ltd.FMK2026-03-16
08809262393224Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393231Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393248Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393255Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393392Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393408Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393415Sterilized Eol Auto LancetHLB CO.,LTDFMK2025-08-20
08809262393422Sterilized Eol Auto LancetHLB CO.,LTDFMK2025-08-20
08809262393439Sterilized Eol Auto LancetHLB CO.,LTDFMK2025-08-20
08809262393460Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393477Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393484Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20