FDA UDI
In Commercial Distribution
🇺🇸 United States
Healite II
DI: 08809447651699
·
Model: Healite Body Assy
·
Lutronic Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Healite II
- Primary DI
- 08809447651699
- Version / Model
- Healite Body Assy
- Company Name
- Lutronic Corporation
- Labeler DUNS
- 688282516
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 8
- Public Version Date
- 2026-01-05
- Public Version Status
- Update
- Public Device Record Key
- 9d09dc36-44c6-43a9-89b9-ac5b4571166c
Device Description
Healite Body Assy (System Main Body)
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
- No
- 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 |
|---|---|---|---|---|
| 45688 | Red-light phototherapy unit, professional | An electrically-powered device designed to emit red light for phototherapy primarily to accelerate healing of cutaneous/mucosal wounds, treat mild skin disorders (e.g., mild acne), intraoral or nasal conditions, and/or treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood circulation. It is a non-wearable device which may be in the form of a hand-held, freestanding or mounted unit, and is intended to be used by a healthcare professional in a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 8809447651705 | GS1 | carton case | 1 | In Commercial Distribution | |
| Primary | 08809447651699 | GS1 |
Customer Contacts
- Phone
- 215-205-2219
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 70 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 20 – 30 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 70 Percent (%) Relative Humidity