Twist Lancet (28G)

FDA UDI

Class II (US FDA UDI)

by Shandong Lianfa Medical Plastic Products CO., LTD

Identity

Trade Name: Twist Lancet (28G) FDA UDI
Generic Name: Blood lancet, single-use FDA UDI
Device Name: Sterile Lancet for Single Use (Bag of 200 lancets), sterilized with Ethylene Oxide FDA UDI
Model / Reference: LF-TL-28 FDA UDI
Description: Sterile Lancet for Single Use (Bag of 200 lancets), sterilized with Ethylene Oxide FDA UDI

Identifiers

Primary DI / UDI-DI: 06949517000476 FDA UDI
FDA Product Code: QRL FDA UDI
GMDN Term: Blood lancet, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4850 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Blood lancet, single-use

Twist Lancet (28G) by Shandong Lianfa Medical Plastic Products CO., LTD — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Shandong Lianfa Medical Plastic Products CO., LTD

Sources (1)

FDA UDI b54a9f88-4088-443f-8a09-2e9246bfc6c0 33 fields · synced May 30, 2026