FDA UDI
In Commercial Distribution
🇺🇸 United States
Lightning X Products, Inc
DI: 06946430425072
·
Model: COL007
·
XIAMEN COMPOWER MEDICAL TECH. CO., LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Lightning X Products, Inc
- Primary DI
- 06946430425072
- Version / Model
- COL007
- Company Name
- XIAMEN COMPOWER MEDICAL TECH. CO., LTD
- Labeler DUNS
- 543482946
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-24
- Public Version
- 1
- Public Version Date
- 2026-01-01
- Public Version Status
- New
- Public Device Record Key
- cb69ebb9-e3d4-4798-9639-7ca378f45170
Device Description
The collar is a one-piece rigid cervical spine immobilization device designed to assist the rescuer with the maintenance of neutral alignment, prevention of lateral (side-to-side) sway and anterior-posterior (forward and backward) flexion and extension of the cervical spine during patient transport or movement.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IQK | Orthosis, Cervical | Physical Medicine | 890.3490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45129 | Cervical spine collar, single-use | A prefabricated (non-customized) padded device that is worn around the neck and intended to support or immobilize the cervical spine to treat deformities, fractures, sprains, or strains (often to treat whiplash resulting from an automobile accident). This device will provide support to the head while limiting movement of the cervical vertebrae. It is available in a variety of sizes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16946430425079 | GS1 | carton | 25 | In Commercial Distribution | |
| Primary | 06946430425072 | GS1 |