FDA UDI
In Commercial Distribution
🇺🇸 United States
Flat Window
DI: 00854103007233
·
Model: PRD-000233-000-L
·
LITECURE LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Flat Window
- Primary DI
- 00854103007233
- Version / Model
- PRD-000233-000-L
- Company Name
- LITECURE LLC
- Labeler DUNS
- 858768943
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-30
- Public Version
- 1
- Public Version Date
- 2022-07-08
- Public Version Status
- New
- Public Device Record Key
- 205f89fd-34fc-4325-99b9-b2ad9f521824
Device Description
BDA Attachment head Flat Window
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| 63541 | Musculoskeletal/physical therapy laser beam guide tip, transcutaneous | A device intended to be connected to a hand-held laser beam guide to deliver visible red/infrared laser light energy to the skin-surface for localized treatment of underlying musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation. It incorporates fibreoptic/light transmitting materials and is intended to connect to the distal end of the applicator, and may include features to allow for manual massage as an adjunct to laser energy therapy (e.g., integrated massage ball). It is intended to be operated by a healthcare professional exclusively in a clinical setting. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00854103007233 | GS1 |