FDA.report

SureComfort Safety Lancet

Primary DI
08809262393743
Brand
SureComfort Safety Lancet
Company
HLB CO.,LTD
Model
LBAL 30G
Published
2025-08-20
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

Related Records

Contact Domains

Product Codes

CodeName
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Product Code Classifications

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

Premarket Submissions

SubmissionSupplement
K243533000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K243533000Sterilized Eol Auto Lancet; Sterilized Eol Lancet PlusHlb Co., Ltd. Healthcare2025-01-13FMK

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809262393743PrimaryGS10
08809262393903Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809262393743088092623937438809262393743
08809262393903088092623939038809262393903

GMDN Terms

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

Contacts

PhoneEmail
+448629134qa2@hlbbio.co.kr

Regulatory Flags

DUNS number
987587913
Device count
100
DM exempt
false
Premarket exempt
false
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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08809262393927Sterilized Eol Lancet PlusHCG LANCET 28G2025-08-20
08809262393934Sterilized Eol Lancet PlusHCG LANCET 30G2025-08-20
08809262393873Sterilized Eol Auto LancetLBAL 26G2025-08-20
08809262393880Sterilized Eol Auto LancetLBAL 28G2025-08-20
08809262393897Sterilized Eol Auto LancetLBAL 30G2025-08-20
08809262393910Sterilized Eol Lancet PlusHCG LANCET 26G2025-08-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
26931918108718AllesetGRI Medical & Electronic Technology Co., Ltd.FMK2026-03-16
36945630141981STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-03-09
06945630141997STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-03-09
30885632507070MedichoiceOWENS & MINOR DISTRIBUTION, INC.FMK2026-02-17
00843484108356Ever Ready First AidSZY HOLDINGS, LLCFMK2026-02-13
00843484108370Ever Ready First AidSZY HOLDINGS, LLCFMK2026-02-13
10848530107557DiabeticsSUNSET HEALTHCARE SOLUTIONS, INC.FMK2025-12-19
04719893237139TD-5052 AKTIVSAFE LANCET (Sterile) (21G) (100PCS/BOX)TAIDOC TECHNOLOGY CORPORATIONFMK2025-11-25
04719893237153TD-5052 AKTIVSAFE LANCET (Sterile) (26G) (100PCS/BOX)TAIDOC TECHNOLOGY CORPORATIONFMK2025-11-25
04719893237177TD-5052 AKTIVSAFE LANCET (Sterile) (30G) (100PCS/BOX)TAIDOC TECHNOLOGY CORPORATIONFMK2025-11-25
01850011833123VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833192VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833215VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833222VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833284VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833291VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833307VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833314VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833338VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833352VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833369VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833376VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833383VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833390VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833406VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833413VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833451VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833468VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833512VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833819VerifinePromisemed Medical Devices Inc.FMK2025-11-20