FDA UDI
In Commercial Distribution
🇺🇸 United States
Saturn 5 Laser System
DI: 05060170183786
·
Model: Saturn 5 Laser System Fixed with RI Viewer Software
·
RESEARCH INSTRUMENTS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Saturn 5 Laser System
- Primary DI
- 05060170183786
- Version / Model
- Saturn 5 Laser System Fixed with RI Viewer Software
- Catalog Number
- 6-47-501
- Company Name
- RESEARCH INSTRUMENTS LIMITED
- Labeler DUNS
- 536139413
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-12-22
- Public Version
- 4
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- 59ab8564-ee61-4e11-8338-c3b1060a3356
Device Description
Assisted Reproduction Laser
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 | 05060170183786 | GS1 |
Customer Contacts
- Phone
- 4546790202
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141434 | 000 |