FDA UDI
In Commercial Distribution
🇺🇸 United States
Maquet Rolite
DI: 03700712432508
·
Model: ARDROL309055A
·
MAQUET SAS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Maquet Rolite
- Primary DI
- 03700712432508
- Version / Model
- ARDROL309055A
- Company Name
- MAQUET SAS
- Labeler DUNS
- 264700139
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-20
- Public Version
- 1
- Public Version Date
- 2024-06-28
- Public Version Status
- New
- Public Device Record Key
- e49bbcd3-5eb5-41b4-9302-07f51c7c6f0a
Device Description
ROLM EZEA30SF B
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| FSS | Light, surgical, floor standing | General, Plastic Surgery | 878.4580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36843 | Mobile examination/treatment room light | A mobile 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), which reflect the light via reflectors or mirrors depending upon the construction, and will often be mounted on a pantograph counterbalance assembly that is attached to a mobile mount. It is usually used during examination or treatment in locations that do not have the required lighting installed. This device is designed to be easily moved from one location to another. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03700712432508 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 60 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- -10 – 60 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 75 Percent (%) Relative Humidity