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MiniCollect® PIXIE Heel Incision Safety Lancet

FDA UDI

Class II (US FDA UDI)

by Sterilance Medical (Suzhou) Inc.

Identity

Trade Name
MiniCollect® PIXIE Heel Incision Safety Lancet FDA UDI
Generic Name
Manual blood lancing device, single-use FDA UDI
Device Name
MINICOLLECT PIXIE Heel Incision Safety Lancet,0.85*1.75mm,50Lancets/box FDA UDI
Model / Reference
450526 FDA UDI
Description
MINICOLLECT PIXIE Heel Incision Safety Lancet,0.85*1.75mm,50Lancets/box FDA UDI

Identifiers

Primary DI / UDI-DI
16945630109833 FDA UDI
510(k) Number
K210745 FDA UDI
FDA Product Code
FMK FDA UDI
GMDN Term
Manual blood lancing device, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4850 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

MiniCollect® PIXIE Heel Incision Safety Lancet by Sterilance Medical (Suzhou) Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K210745 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sterilance Medical (Suzhou) Inc.

Sources (1)

  • FDA UDI e4ba1a5a-29d1-497f-8965-8d0fb14b0373 35 fields · synced May 30, 2026