FDA.reportPublic FDA data

Acti-Lance, safety lancet

Primary DI
15901549097013
Brand
Acti-Lance, safety lancet
Company
HTL STREFA S A
Model
Lite, 28G
Catalog number
7155
Device description
Safety lancets are sterile, single use medical devices intended for capillary blood sampling. Intended users are healthcare professionals and lay users.
Published
2020-05-17
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

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
15901549097013PackageGS120In Commercial Distribution
05901549097016PrimaryGS10
85901549097012Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1590154909701315901549097013
05901549097016059015490970165901549097016
8590154909701285901549097012

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+48422700010info@htl-strefa.com

Regulatory Flags#

DUNS number
422528088
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
false
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
05903999601775DropSafe, safety pen needles31G x 6mm84322022-09-28
05903999601782DropSafe, safety pen needles31G x 8mm84332022-09-28
05903999601799DropSafe, safety pen needles31G x 5mm87972022-09-28
00857273002992droplet® pen needles32G x 6mm 75202026-04-21
05907996093045droplet® pen needles29G x 12mm83082016-09-22
05907996093069droplet® pen needles31G x 5mm83102016-09-22
05907996093038droplet® pen needles29G x 10mm83072016-09-22
05907996093052droplet® pen needles31G x 8mm83092016-09-22
00857273002473Clickfine® pen needles31G x 5 mm78092026-02-17
00857273002480Clickfine® pen needles31G x 6 mm97492026-02-17
00857273002541Clickfine® pen needles31G x 8 mm97282026-02-17
00857273002558Clickfine® pen needles32G x 4 mm97512026-02-17
10857273002470Clickfine® pen needles31G x 5 mm78092026-02-17
10857273002487Clickfine® pen needles31G x 6 mm97492026-02-17
10857273002548Clickfine® pen needles31G x 8 mm97282026-02-17
10857273002555Clickfine® pen needles32G x 4 mm97512026-02-17
05907996090327Droplet, Lancing Devicen/a90062019-11-01
05901549097535droplet ® personal lancet33G72062019-12-01
05901549097542droplet ® personal lancet33G72072019-12-01
05907506237037Medlance, safety lancet21G 2.4mm70022020-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
16945630137799STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-04-19
16945630137805STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-04-19
16945630137812STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-04-19
16945630137829STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-04-19
16931918108711AllesetGRI Medical & Electronic Technology Co., Ltd.FMK2026-03-16
16945630141987STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-03-09
16945630141994STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-03-09
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