FDA UDI
In Commercial Distribution
🇺🇸 United States
OmniOptic™ Plano - Dragonfly™
DI: 00615375014479
·
Model: .*.OMNI.DRAGONFLY * (GEN 2).*, Plano
·
METREX RESEARCH, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OmniOptic™ Plano - Dragonfly™
- Primary DI
- 00615375014479
- Version / Model
- .*.OMNI.DRAGONFLY * (GEN 2).*, Plano
- Company Name
- METREX RESEARCH, LLC
- Labeler DUNS
- 145963778
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-28
- Public Version
- 1
- Public Version Date
- 2025-05-06
- Public Version Status
- New
- Public Device Record Key
- 13342f09-7646-48d0-8636-89a3efd79adb
Device Description
Dragonfly™ powered loupe with OmniOptic™ plano oculars
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
- Yes
- 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 |
|---|---|---|---|---|
| FSP | Loupe, Diagnostic/Surgical | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32692 | Surgical binoculars, reusable | A pair of lenses intended to be mounted onto a surgeon's spectacles to function as small telescope and provide a magnified image of the visual field during patient examination or surgical intervention. Also known as a surgical loupe, it may be mounted onto the spectacle frames and positioned in front of the spectacle lenses or attached directly onto each of the spectacle lenses. It may also be connected to an external light source or a head-worn light for visual field illumination. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00615375014479 | GS1 |
Customer Contacts
- Phone
- 1.800.369.3698
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)