Parkell®

FDA UDI

Class II (US FDA UDI)

by Parkell, Inc.

Identity

Trade Name: Parkell® FDA UDI
Generic Name: Mechanical pipette FDA UDI
Device Name: POLYETHYLENE PLASTIC PIPETS/DROPPERS (Pkg. of 25 pcs.) FDA UDI
Model / Reference: S421 FDA UDI
Description: POLYETHYLENE PLASTIC PIPETS/DROPPERS (Pkg. of 25 pcs.) FDA UDI

Identifiers

Catalog Number: S421 FDA UDI
Primary DI / UDI-DI: 10810000527035 FDA UDI
FDA Product Code: EBG FDA UDI
GMDN Term: Mechanical pipette FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3770 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Mechanical pipette

Parkell® by Parkell, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mechanical pipette.

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Wallace — ICU MEDICAL, INC. · Class II
Wallace — ICU MEDICAL, INC. · Class II
LabChoice Mechanical Pipette, Single Channel, Adjustable Volume 0.5 - 5 ML — Dynarex Corp. · Class I
Sunbiotec — Hubei Huamei Sunlight Biotechnologies Co., Ltd · Class II
Wallace — ICU MEDICAL, INC. · Class II
SLM — Sunlight Medical, Inc. · Class II

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: Parkell, Inc.

Sources (1)

FDA UDI a944893e-3896-4541-b1b1-c8aaab4bb549 35 fields · synced Jun 1, 2026