FDA UDI
In Commercial Distribution
🇺🇸 United States
Applicator 9402
DI: 00816864020678
·
Model: 9402
·
METTLER ELECTRONICS CORP.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Applicator 9402
- Primary DI
- 00816864020678
- Version / Model
- 9402
- Catalog Number
- 9402
- Company Name
- METTLER ELECTRONICS CORP.
- Labeler DUNS
- 008513913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 5dd0669c-99fc-46f5-9db1-a411751e4047
Device Description
940 applicator (Small size/ 1 & 3 MHz)
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
- Yes
- 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 |
|---|---|---|---|---|
| GZJ | STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | Neurology | 882.5890 | 2 |
| IMG | STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT | Physical Medicine | 890.5860 | 2 |
| LIH | INTERFERENTIAL CURRENT THERAPY | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40774 | Physical therapy ultrasound system applicator | A hand-held component of a physical therapy ultrasound system that includes a transdcer designed to convert electric voltages into ultrasound energy [e.g., frequencies greater than 20 kilohertz (kHz)] and directs this energy into body tissues. The localized thermal and nonthermal effects generated by the ultrasonic energy is associated with increased blood flow in the treated area and is intended to accelerate tissue repair. The device is typically used with ultrasound coupling gels to ensure an adequate interface with the patient. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816864020678 | GS1 |
Customer Contacts
- Phone
- +1(714)533-2221 ext. 319
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K071137 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 167 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- No