FDA UDI
In Commercial Distribution
🇺🇸 United States
MIRA Minor Surgery Light
DI: 00667774000072
·
Model: MIRA
·
Amico Lights Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MIRA Minor Surgery Light
- Primary DI
- 00667774000072
- Version / Model
- MIRA
- Catalog Number
- L-MLED50-WM-XX-EX
- Company Name
- Amico Lights Corporation
- Labeler DUNS
- 203021407
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-09
- Public Version
- 4
- Public Version Date
- 2021-01-08
- Public Version Status
- Update
- Public Device Record Key
- fc5e9a51-aa91-4b88-89a3-3d00bbcdb4c9
Device Description
Mira LED 50, Wall Mount, Extended Arm
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| FSY | Light, Surgical, Ceiling Mounted | General, Plastic Surgery | 878.4580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12276 | Fixed examination/treatment room light | A fixed device intended to provide light to illuminate a site of patient examination and/or treatment. It typically consists of one or more light bulb(s) and, depending upon the design, reflectors or mirrors which focus and reflect the light. The device can be fixed to a ceiling, wall, or supported on a mobile mount. It can also be part of an operating light system consisting of more than one light head. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00667774000072 | GS1 |
Customer Contacts
- Phone
- (905) 764-0800
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131893 | 000 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity