FDA.reportPublic FDA data

SafetiCet

Primary DI
08887629000022
Brand
SafetiCet
Company
NSP TECH PTE LTD
Model
SC-150
Catalog number
SC-150-010
Device description
A sterile and single use device, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider or a patient (e.g., a diabetic), typically at the fingertip. It includes a preloaded 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
Published
2021-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMKLancet, Blood

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08887629000039PackageGS150In Commercial Distribution
08887629000046PackageGS1100In Commercial Distribution
18887629000036PackageGS140In Commercial Distribution
18887629000043PackageGS120In Commercial Distribution
08887629000015PrimaryGS10
18887629000029PrimaryGS10
08887629000022Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08887629000039088876290000398887629000039
08887629000046088876290000468887629000046
1888762900003618887629000036
1888762900004318887629000043
08887629000015088876290000158887629000015
1888762900002918887629000029
08887629000022088876290000228887629000022

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth1.5Millimeter
Needle Gauge28Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Not exposed to direct sunlight

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+6565551315enquiry@nsptech.com.sg
+6567478817enquiry@nsptech.com.sg

Regulatory Flags#

DUNS number
653632729
Device count
200
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08887629000008BUHBUH2026-05-29
08887629000053BUCABUCA2026-05-29
08887629000060BTABTA2026-05-29
08887629010007SAFETIHEELSH-0652026-05-29
08887629010106SAFETIHEELSH-0852026-05-29
08887629010205SAFETIHEELSH-1002026-05-29
08887629010304SAFETIHEELSH-1502026-05-29
18887629000029SafetiCetSC-150SC-150-0102021-04-30
08887629000114SAFETICETSC-1802022-04-26
08887629000312SAFETICETSC-2502022-04-25
08887629000213SAFETICETSC-2202022-04-20
08887629000015SAFETICETSC-1502022-04-26
08887629000718SAFETICETSC-250B2023-08-11
08887629000725SAFETICETSC-250B2023-08-11
08887629000121SAFETICETSC-1802022-04-26
08887629000244SAFETICETSC-2202022-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
16931918130408Cardinal HealthGRI Medical & Electronic Technology Co., Ltd.FMK2025-06-20
16931918166803Cardinal HealthGRI Medical & Electronic Technology Co., Ltd.FMK2025-06-20
16945630132435STERiLANCE Elite Disposable Safety LancetSterilance Medical (Suzhou) Inc.FMK2024-10-23