FDA UDI
In Commercial Distribution
🇺🇸 United States
Midmark
DI: 00841709110375
·
Model: 153604LRCA-E
·
MIDMARK CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Midmark
- Primary DI
- 00841709110375
- Version / Model
- 153604LRCA-E
- Catalog Number
- 153604LRCA-E
- Company Name
- MIDMARK CORPORATION
- Labeler DUNS
- 005036025
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-22
- Public Version
- 1
- Public Version Date
- 2020-06-01
- Public Version Status
- New
- Public Device Record Key
- 33eac54b-e058-4c5e-b6be-58e7817d0554
Device Description
Midmark Procenter LR Concept (Midmark Elevance Chairs) Cuspidor and Assistant's Combination Unit Systems are intended to provide dental professionals with air, water and suction to operate dental handpieces, syringes, and Midmark authorized accessories during dental examinations and procedures.
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 |
|---|---|---|---|---|
| EIA | Unit, operative dental | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60930 | Dental delivery system instrument unit, electric | A mains electricity (AC-powered) device designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), sometimes with a control panel for setting various operating parameters; it may be portable or mounted. The device is commonly referred to as a dental unit or dental operative unit and is intended to be operated by a healthcare professional in a medical facility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841709110375 | GS1 |
Customer Contacts
- Phone
- +1(800)643-6275
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K003090 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -5 – 38 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- -5 – 38 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity