FDA.reportPublic FDA data

Twist Lancet (32G)

Primary DI
06949517000780
Brand
Twist Lancet (32G)
Company
Shandong Lianfa Medical Plastic Products CO.,LTD
Model
LF-TL-32
Device description
Sterile Lancet for Single Use (Bag of 30 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

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
06949517000780PrimaryGS10
56949517061649Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06949517000780069495170007806949517000780
5694951706164956949517061649

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

Regulatory Flags#

DUNS number
421330121
Device count
30
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 DI, Brand, Model table
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 DI, Brand, Company table
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
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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