FDA UDI
In Commercial Distribution
🇺🇸 United States
Midmark
DI: 00841709107641
·
Model: 153963-008
·
MIDMARK CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Midmark
- Primary DI
- 00841709107641
- Version / Model
- 153963-008
- Catalog Number
- 153963-008
- Company Name
- MIDMARK CORPORATION
- Labeler DUNS
- 005036025
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-31
- Public Version
- 2
- Public Version Date
- 2021-01-08
- Public Version Status
- Update
- Public Device Record Key
- 7c1d2205-a611-4ef8-9842-fd0cdcd0af4c
Device Description
The Midmark 128 inch Dental Track Light with 24 inch Monitor is intended to be used as a component in a dental environment to provide lighting during dental procedures.
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 |
|---|---|---|---|---|
| EAZ | LIGHT, OPERATING, DENTAL | Dental | 872.4630 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12351 | Reflective dental room light | A mains electricity (AC-powered) device designed for use in dentistry to project an intense and focused beam of light typically into or around the oral cavity of a patient to illuminate the site of a dental examination or procedure. It is constructed as a curved reflector with a dedicated central light bulb that produces and focuses the light, an outer housing with handles for dental staff to hold when manoeuvring the light head, and a jointed support arm. This device may be incorporated into a dental delivery system or be fixed separately to the ceiling or other support. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841709107641 | GS1 |
Customer Contacts
- Phone
- +1(800)643-6275
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -5 – 38 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -5 – 38 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity