Primary Device ID | 00858604006276 |
NIH Device Record Key | 831fd781-c052-4d84-819d-1ab682679274 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ZILOS-tk™ |
Version Model Number | ZILOS-tk |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00858604006276 [Primary] |
MRX | System, Assisted Reproduction Laser |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-12-09 |
Device Publish Date | 2019-11-30 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ZILOS-TK 78205724 2800416 Live/Registered |
HAMILTON THORNE, INC. 2003-01-22 |