FDA.reportPublic FDA data

SAFETIHEEL

Primary DI
08887629010007
Brand
SAFETIHEEL
Company
NSP TECH PTE LTD
Model
SH-065
Published
2026-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
K221604000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221604000SafetiHeel, MediHeel, NovaplusNsp Tech Pte, Ltd.2022-08-22FMK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08887629010014PackageGS15In Commercial Distribution
08887629010038PackageGS150In Commercial Distribution
18887629010011PackageGS15In Commercial Distribution
18887629010035PackageGS150In Commercial Distribution
08887629010007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08887629010014088876290100148887629010014
08887629010038088876290100388887629010038
1888762901001118887629010011
1888762901003518887629010035
08887629010007088876290100078887629010007

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
Depth0

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
+16463518664enquiry@nsptech.com.sg
+6567478817enquiry@nsptech.com.sg

Regulatory Flags#

DUNS number
653632729
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08887629000008BUHBUH2026-05-29
08887629000053BUCABUCA2026-05-29
08887629000060BTABTA2026-05-29
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
08887629000022SafetiCetSC-150SC-150-0102021-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382830006705NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00382830006712NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00840117346505PA Safety Lancets, Pressure Activated, 21 G NeedleDynarex CorporationFMK2026-06-01
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
16945630132442STERiLANCE Elite Disposable Safety LancetSterilance Medical (Suzhou) Inc.FMK2024-10-23
16945630132466STERiLANCE Elite Disposable Safety LancetSterilance Medical (Suzhou) Inc.FMK2024-10-23