Quality Choice Unilet

FDA UDI

Class II (US FDA UDI)

by Chain Drug Marketing Association, Inc.

Identity

Trade Name: Quality Choice Unilet FDA UDI
Generic Name: Blood lancing device tip FDA UDI
Device Name: Quality Choice Unilet Lancets Super Thin 30 Gauge for Sensitive Fingers FDA UDI
Model / Reference: AT 0575QC FDA UDI
Description: Quality Choice Unilet Lancets Super Thin 30 Gauge for Sensitive Fingers FDA UDI

Identifiers

Primary DI / UDI-DI: 00635515959354 FDA UDI
FDA Product Code: QRK FDA UDI
GMDN Term: Blood lancing device tip 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 30 Gauge FDA UDI

Category: Blood lancing device tip

Quality Choice Unilet by Chain Drug Marketing Association, Inc. — 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: Chain Drug Marketing Association, Inc.

Sources (1)

FDA UDI c259f214-8167-48ac-a64e-0bac4d1ab8af 34 fields · synced Jun 8, 2026