FDA.report

Sterilized Eol Auto Lancet

Primary DI
08809262393873
Brand
Sterilized Eol Auto Lancet
Company
HLB CO.,LTD
Model
LBAL 26G
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
08809262393415PrimaryGS10
08809262393873Unit of UseGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorEAN-13Conversion note
08809262393415140880926239341508809262393415Indicator 0 allows EAN-13 conversion; UPC-A requires prefix 00.
08809262393873140880926239387308809262393873Indicator 0 allows EAN-13 conversion; UPC-A requires prefix 00.

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
+82448629134qa2@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
08809262393880Sterilized Eol Auto LancetLBAL 28G2025-08-20
08809262393897Sterilized Eol Auto LancetLBAL 30G2025-08-20
08809262393910Sterilized Eol Lancet PlusHCG LANCET 26G2025-08-20
08809262393743SureComfort Safety LancetLBAL 30G2025-08-20

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30885632507070MedichoiceOWENS & MINOR DISTRIBUTION, INC.FMK2026-02-17
00843484108356Ever Ready First AidSZY HOLDINGS, LLCFMK2026-02-13
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10848530107557DiabeticsSUNSET HEALTHCARE SOLUTIONS, INC.FMK2025-12-19
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