MICROTOOLS (Transfer Pipette)

GUDID 07540268000068

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 Transfer Pipette is to be used by qualified personnel during In-Vitro Fertilization (IVF) or Assisted Reproduction Technology (ART) procedures in vitro, to separate cumulus-oocyte complexes (COCs) into washing or culture dishes after oocyte collection. The Transfer Pipette is also used for transferring COCs into hyaluronidase solution to denude cumulus cells from oocytes. Intended for one-time use.

Arsci Inc.

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Primary Device ID07540268000068
NIH Device Record Keyeb003a5f-3463-4151-b611-3f1a10751f38
Commercial Distribution StatusIn Commercial Distribution
Brand NameMICROTOOLS (Transfer Pipette)
Version Model NumberTP-1200
Company DUNS241975256
Company NameArsci Inc.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone450-674-6886
Emailraina@arsci.ca
Phone450-674-6886
Emailraina@arsci.ca
Phone450-674-6886
Emailraina@arsci.ca
Phone450-674-6886
Emailraina@arsci.ca
Phone450-674-6886
Emailraina@arsci.ca
Phone450-674-6886
Emailraina@arsci.ca
Phone450-674-6886
Emailraina@arsci.ca
Phone450-674-6886
Emailraina@arsci.ca
Phone450-674-6886
Emailraina@arsci.ca
Phone450-674-6886
Emailraina@arsci.ca
Phone450-674-6886
Emailraina@arsci.ca
Phone450-674-6886
Emailraina@arsci.ca
Phone450-674-6886
Emailraina@arsci.ca
Phone450-674-6886
Emailraina@arsci.ca
Phone450-674-6886
Emailraina@arsci.ca

Device Identifiers

Device Issuing AgencyDevice ID
GS107540268000068 [Unit of Use]
GS107540268000877 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQHMicrotools, Assisted Reproduction (Pipettes)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-17
Device Publish Date2022-10-07

Devices Manufactured by Arsci Inc.

07540268000044 - MICROTOOLS (Denuding Pipette)2022-10-17 A non-invasive, single-use micro-manipulation pipette used in the laboratory to inject, denude, mobilize, remove, aspirate, inci
07540268000020 - MICROTOOLS (Assisted Hatching Pipette)2022-10-17 A non-invasive, single-use micro-manipulation pipette used in the laboratory to inject, denude, mobilize, remove, aspirate, inci
07540268000068 - MICROTOOLS (Transfer Pipette)2022-10-17A 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 Transfer Pipette is to be used by qualified personnel during In-Vitro Fertilization (IVF) or Assisted Reproduction Technology (ART) procedures in vitro, to separate cumulus-oocyte complexes (COCs) into washing or culture dishes after oocyte collection. The Transfer Pipette is also used for transferring COCs into hyaluronidase solution to denude cumulus cells from oocytes. Intended for one-time use.
07540268000068 - MICROTOOLS (Transfer Pipette)2022-10-17 A non-invasive, single-use micro-manipulation pipette used in the laboratory to inject, denude, mobilize, remove, aspirate, inci

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