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MICROTOOLS (Holding Pipette)

FDA UDI

Class II (US FDA UDI)

by Arsci Inc.

Identity

Trade Name
MICROTOOLS (Holding 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 Holding Pipette is to be used by qualified personnel during In-Vitro Fertilization (IVF) or Assisted Reproduction Technology (ART) procedures in vitro, to secure the mature oocyte for when the Injection Pipette (or ICSI pipette) is utilized in the intracytoplasmic sperm injection (ICSI) of oocytes. The Holding Pipette also can help to ensure immobility of an embryo during biopsy procedures. Intended for one-time use. FDA UDI
Model / Reference
H-3003 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 Holding Pipette is to be used by qualified personnel during In-Vitro Fertilization (IVF) or Assisted Reproduction Technology (ART) procedures in vitro, to secure the mature oocyte for when the Injection Pipette (or ICSI pipette) is utilized in the intracytoplasmic sperm injection (ICSI) of oocytes. The Holding Pipette also can help to ensure immobility of an embryo during biopsy procedures. Intended for one-time use. FDA UDI

Identifiers

Primary DI / UDI-DI
07540268000211 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Category: Assisted reproduction microtool

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

Similar devices

Also classified as Assisted reproduction microtool.

Cleared under the same submission

K102480 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Arsci Inc.

Sources (1)

  • FDA UDI fa4149a9-7789-43a3-8c31-92f0202805dd 35 fields · synced May 30, 2026