FDA.report

Safety Lancet (21G)

Primary DI
06949517001091
Brand
Safety Lancet (21G)
Company
Shandong Lianfa Medical Plastic Products CO.,LTD
Model
LF-PA-21
Device description
Pressure Activated Safety Lancet (Box of 200 lancets), sterilized with Ethylene Oxide
Published
2019-04-30
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

Related Records

Product Codes

CodeName
FMKLancet, Blood

Product Code Classifications

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06949517001091PrimaryGS10
56949517062097Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06949517001091069495170010916949517001091
5694951706209756949517062097

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

Regulatory Flags

DUNS number
421330121
Device count
200
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
true
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
06949517006201N/MLDC2026-01-31
06949517009462N/MLDC2025-12-10
06949517009028One +StepLDE2025-09-14
56949517070894One +StepLF-TL-23-I2025-06-27
56949517070900One +StepLF-TL-28-I2025-06-27
56949517070917One +StepLF-TL-30-II2025-06-27
06949517008878One +StepLDE2025-06-27
56949517070887Twist Lancet(30G)LF-TL-302024-11-01
06949517007024N/MLDF2024-05-28
56949517070757Twist Lancet (30G)LF-TL-302021-11-18
56949517070764Twist Lancet (30G)LF-TL-302021-11-18
56949517070870LinkfarLF-TL-282024-03-19
06949517006362TysonBioLF-TL-302023-07-15
56949517070795plusmed LF-TL-302023-07-16
56949517070801TysonBioLF-TL-282023-07-16
56949517070818TysonBioLF-TL-302023-07-16
56949517070825TysonBioLF-TL-302023-07-16
56949517070832TysonBioLF-TL-302023-07-16
56949517070849TysonBioLF-TL-302023-07-16
06949517006430TysonBioLF-TL-302023-07-16

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
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