MICROTOOLS (Denuding Pipette)

GUDID 07540268000044

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.

Arsci Inc.

Assisted reproduction microtool

• Primary Device ID: 07540268000044
• NIH Device Record Key: d2c7563c-af1e-440b-a55f-63aa3d84b526
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MICROTOOLS (Denuding Pipette)
• Version Model Number: D-250
• Company DUNS: 241975256
• Company Name: Arsci Inc.
• Device Count: 50
• 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

• 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
• 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	07540268000044 [Unit of Use]
GS1	07540268000280 [Primary]
GS1	07540268000310 [Primary]
GS1	07540268000341 [Primary]
GS1	07540268000372 [Primary]
GS1	07540268000402 [Primary]
GS1	07540268000433 [Primary]
GS1	07540268000464 [Primary]
GS1	07540268000495 [Primary]
GS1	07540268000525 [Primary]
GS1	07540268000549 [Primary]
GS1	07540268000556 [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): 2022-10-17A 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 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.
• 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): 2022-10-17 A non-invasive, single-use micro-manipulation pipette used in the laboratory to inject, denude, mobilize, remove, aspirate, inci