LYKOS™

GUDID 00858604006290

This system is intended to be used to drill a small tangential bole in or to thin the zona pellucida of the embryo in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome, such as advanced maternal age, prior failed IVF procedures, cryopreserved embryos, or abnormal zona pellucida morphology, and in lyE patients undergoing PGD to avoid genetic disease or aneuploidy.

HAMILTON THORNE, INC.

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• Primary Device ID: 00858604006290
• NIH Device Record Key: 1b5fd387-60f3-4722-951b-02bfd8ed9d38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LYKOS™
• Version Model Number: LYKOS
• Company DUNS: 152161337
• Company Name: HAMILTON THORNE, INC.
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858604006290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120055

FDA Product Code

• MRX: System, Assisted Reproduction Laser

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-09
• Device Publish Date: 2019-11-30

Devices Manufactured by HAMILTON THORNE, INC.

• 00858604006054 - LYKOS DTS: 2023-06-15 This system is intended for in vitro fertilization (IVF) laboratory use to ablate a small, tangential hole or thin the zona pell
• 00858604006016 - accu-beads®: 2022-04-07 accu-beads® are intended for use as a quality control material to assist in verifying the accuracy and precision of manual and
• 00858604006146 - GM501 Gradient 45%: 2021-05-10 GM501 Gradient 45% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICS
• 00858604006177 - GM501 Gradient 90%: 2021-05-10 GM501 Gradient 90% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICS
• 00858604006184 - GM501 Gradient 90%: 2021-05-10 GM501 Gradient 90% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICS
• 00858604006191 - GM501 Gradient 90%: 2021-05-10 GM501 Gradient 90% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICS
• 00858604006207 - GM501 Gradient 90%: 2021-05-10 GM501 Gradient 90% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICS
• 00858604006214 - GM501 Gradient 100%: 2021-05-10 GM501 Gradient 100% is a stock solution for semen preparation. It is a ready-to-use isotonic gradient for semen preparation with