LYKOS DTS

GUDID 00858604006054

This system is intended for in vitro fertilization (IVF) laboratory use to ablate a small, tangential hole or thin the zona pellucida of select IVF embryos to facilitate during assisted reproduction hatching procedures, and to biopsy trophectoderm cells from blastocyst stage embryos for purposes of preimplantation genetic diagnosis or screening.

HAMILTON THORNE, INC.

Assisted reproduction laser system Assisted reproduction laser system Assisted reproduction laser system Assisted reproduction laser system Assisted reproduction laser system Assisted reproduction laser system Assisted reproduction laser system Assisted reproduction laser system Assisted reproduction laser system Assisted reproduction laser system Assisted reproduction laser system Assisted reproduction laser system Assisted reproduction laser system Assisted reproduction laser system Assisted reproduction laser system Assisted reproduction laser system
Primary Device ID00858604006054
NIH Device Record Key116d6782-63ce-4b23-aac0-5d470a39945c
Commercial Distribution StatusIn Commercial Distribution
Brand NameLYKOS DTS
Version Model NumberLYKOS DTS
Company DUNS152161337
Company NameHAMILTON THORNE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858604006054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRXSystem, Assisted Reproduction Laser

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-15
Device Publish Date2023-06-07

Devices Manufactured by HAMILTON THORNE, INC.

00858604006054 - LYKOS DTS2023-06-15This system is intended for in vitro fertilization (IVF) laboratory use to ablate a small, tangential hole or thin the zona pellucida of select IVF embryos to facilitate during assisted reproduction hatching procedures, and to biopsy trophectoderm cells from blastocyst stage embryos for purposes of preimplantation genetic diagnosis or screening.
00858604006054 - LYKOS DTS2023-06-15 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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.