MICROTOOLS (Injection Pipiette)

FDA UDI

Class II (US FDA UDI)

by Arsci Inc.

Identity

Trade Name: MICROTOOLS (Injection Pipiette) 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 Injection Pipette (or ICSI pipette) is to be used by qualified personnel during In-Vitro Fertilization (IVF) or Assisted Reproduction Technology (ART) procedures in vitro, to inject a single sperm directly into an oocyte to fertilize it—commonly known as the intracytoplasmic sperm injection (ICSI) of oocytes. Intended for one-time use. FDA UDI
Model / Reference: I-35NP 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 Injection Pipette (or ICSI pipette) is to be used by qualified personnel during In-Vitro Fertilization (IVF) or Assisted Reproduction Technology (ART) procedures in vitro, to inject a single sperm directly into an oocyte to fertilize it—commonly known as the intracytoplasmic sperm injection (ICSI) of oocytes. Intended for one-time use. FDA UDI

Identifiers

Primary DI / UDI-DI: 07540268000099 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 (Injection Pipiette) 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 e58f1f1e-418a-43c2-a144-349dd6951218 35 fields · synced Jun 1, 2026