FDA UDI
In Commercial Distribution
🇺🇸 United States
LYKOS DTS
DI: 00858604006054
·
Model: LYKOS DTS
·
HAMILTON THORNE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LYKOS DTS
- Primary DI
- 00858604006054
- Version / Model
- LYKOS DTS
- Company Name
- HAMILTON THORNE, INC.
- Labeler DUNS
- 152161337
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-07
- Public Version
- 1
- Public Version Date
- 2023-06-15
- Public Version Status
- New
- Public Device Record Key
- 116d6782-63ce-4b23-aac0-5d470a39945c
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MRX | System, Assisted Reproduction Laser | Obstetrics/Gynecology | 884.6200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61181 | Assisted reproduction laser system | A portable, mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a low-intensity laser beam to ablate the zona pellucida of an embryo during in vitro fertilization (IVF), typically as part of laser-assisted embryo hatching or embryo biopsy. It is intended to be used in conjunction with a compatible inverted-stage light microscope and typically includes a combined laser/microscope objective, a control unit, a camera, and additional supportive devices (e.g., software, foot-switch). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858604006054 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202241 | 000 |