MICROTOOLS (Denuding Pipette)

FDA UDI

Class II (US FDA UDI)

by Arsci Inc.

Identity

Trade Name: MICROTOOLS (Denuding Pipette) FDA UDI
Generic Name: Assisted reproduction microtool FDA UDI
Device Name: A non-invasive, single-use micro-manipulation pipette used in the laboratory to inject, denude, mobilize, remove, aspirate, incise, manipulate or separate cells for the duration of In-Vitro Fertilization (IVF), Assisted Reproductive Technologies (ART), and Reproductive Medicine (RM) procedures. The Denuding Pipette is to be used by qualified personnel during In-Vitro Fertilization (IVF) or Assisted Reproduction Technology (ART) procedures in vitro, for the removal or separation of cumulus cells from the oocyte. The Denuding Pipette is also used for transferring oocytes, blastomeres, and embryos. Intended for one-time use. FDA UDI
Model / Reference: D-120 FDA UDI
Description: A non-invasive, single-use micro-manipulation pipette used in the laboratory to inject, denude, mobilize, remove, aspirate, incise, manipulate or separate cells for the duration of In-Vitro Fertilization (IVF), Assisted Reproductive Technologies (ART), and Reproductive Medicine (RM) procedures. The Denuding Pipette is to be used by qualified personnel during In-Vitro Fertilization (IVF) or Assisted Reproduction Technology (ART) procedures in vitro, for the removal or separation of cumulus cells from the oocyte. The Denuding Pipette is also used for transferring oocytes, blastomeres, and embryos. Intended for one-time use. FDA UDI

Identifiers

Primary DI / UDI-DI: 07540268000280 FDA UDI
510(k) Number: K102480 FDA UDI
FDA Product Code: MQH FDA UDI
GMDN Term: Assisted reproduction microtool FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.6130 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

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

Category: Assisted reproduction microtool

MICROTOOLS (Denuding Pipette) by Arsci Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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: Arsci Inc.

Sources (1)

FDA UDI 0b9f8822-4937-4f82-a347-e216740a275c 35 fields · synced Jun 8, 2026