FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Dynatron 880Plus Infrared Cluster Probe
DI: 10660584000437
·
Model: D881
·
Dynatronics Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Dynatron 880Plus Infrared Cluster Probe
- Primary DI
- 10660584000437
- Version / Model
- D881
- Company Name
- Dynatronics Corporation
- Labeler DUNS
- 113399125
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2023-10-31
- Public Version Status
- Update
- Public Device Record Key
- d88d205c-77f7-46a8-86e0-e555c79f12a2
- Distribution End Date
- 2023-10-31
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 |
|---|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | Physical Medicine | 890.5500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45222 | Light-energy skin surface treatment system applicator | A handpiece that is part of a skin surface treatment system that conducts one or more generated light energies [e.g., fluorescent, ultraviolet B (UVB)] used for ablative and non-ablative treatment of skin conditions (e.g., acne, psoriasis, vascular lesions, wrinkles, large pores). This device is connected to a generator and is applied by the practitioner or staff directly to the area to be treated. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10660584000437 | GS1 |
Customer Contacts
- Phone
- 8008746251
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K031329 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 0.5 | Pound |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius