ZILOS-tk™

GUDID 00858604006276

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.

Assisted reproduction laser system
Primary Device ID00858604006276
NIH Device Record Key831fd781-c052-4d84-819d-1ab682679274
Commercial Distribution StatusIn Commercial Distribution
Brand NameZILOS-tk™
Version Model NumberZILOS-tk
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
GS100858604006276 [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 Date2019-12-09
Device Publish Date2019-11-30

Devices Manufactured by HAMILTON THORNE, INC.

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

Trademark Results [ZILOS-tk]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ZILOS-TK
ZILOS-TK
78205724 2800416 Live/Registered
HAMILTON THORNE, INC.
2003-01-22

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