MICROTOOLS (Assisted Hatching Pipette)

GUDID 07540268000020

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 Assisted Hatching Pipette is to be used by qualified personnel during In-Vitro Fertilization (IVF) or Assisted Reproduction Technology (ART) procedures in vitro, to puncture a hole in the zona pellucida to enable embryo assisted hatching using Tyrode’s acid solution. Intended for one-time use.

Arsci Inc.

Assisted reproduction microtool

• Primary Device ID: 07540268000020
• NIH Device Record Key: cc920f13-5056-4560-9b35-6b66a2a0186d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MICROTOOLS (Assisted Hatching Pipette)
• Version Model Number: AH-3501
• Company DUNS: 241975256
• Company Name: Arsci Inc.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

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• Email: raina@arsci.ca
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• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca
• Phone: 450-674-6886
• Email: raina@arsci.ca

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540268000006 [Primary]
GS1	07540268000013 [Primary]
GS1	07540268000020 [Unit of Use]
GS1	07540268000037 [Primary]
GS1	07540268000051 [Primary]
GS1	07540268000075 [Primary]
GS1	07540268000099 [Primary]
GS1	07540268000112 [Primary]
GS1	07540268000136 [Primary]
GS1	07540268000174 [Primary]
GS1	07540268000198 [Primary]
GS1	07540268000211 [Primary]
GS1	07540268000235 [Primary]
GS1	07540268000259 [Primary]
GS1	07540268000570 [Primary]
GS1	07540268000587 [Primary]
GS1	07540268000594 [Primary]
GS1	07540268000600 [Primary]
GS1	07540268000617 [Primary]
GS1	07540268000624 [Primary]
GS1	07540268000631 [Primary]
GS1	07540268000648 [Primary]
GS1	07540268000655 [Primary]
GS1	07540268000662 [Primary]
GS1	07540268000679 [Primary]
GS1	07540268000686 [Primary]
GS1	07540268000693 [Primary]
GS1	07540268000709 [Primary]
GS1	07540268000716 [Primary]
GS1	07540268000723 [Primary]
GS1	07540268000754 [Primary]
GS1	07540268000778 [Primary]
GS1	07540268000815 [Primary]
GS1	07540268000839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102480

FDA Product Code

• MQH: Microtools, Assisted Reproduction (Pipettes)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-17
• Device Publish Date: 2022-10-07

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): 2022-10-17A 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 Assisted Hatching Pipette is to be used by qualified personnel during In-Vitro Fertilization (IVF) or Assisted Reproduction Technology (ART) procedures in vitro, to puncture a hole in the zona pellucida to enable embryo assisted hatching using Tyrode’s acid solution. Intended for one-time use.
• 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): 2022-10-17 A non-invasive, single-use micro-manipulation pipette used in the laboratory to inject, denude, mobilize, remove, aspirate, inci