Identity
- Trade Name
- NECKLITE FDA UDI
- Generic Name
- Cervical spine collar, reusable FDA UDI
- Model / Reference
- YLW FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08057592700117 FDA UDI
- FDA Product Code
- IQF FDA UDI
- GMDN Term
- Cervical spine collar, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3490 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cervical spine collar, reusable
The NECKLITE is a prefabricated, reusable cervical spine collar designed to support and immobilize the neck and head, providing relief from cervical spine injuries and conditions such as whiplash. Made from rigid materials, this orthotic device is available in various sizes and is intended for single-use treatment.
Similar devices
Also classified as Cervical spine collar, reusable.
- WELLBRACE — PANTYMED S.A. · Class I
- VQ ORTHOCARE — Vision Quest Industries Incorporated · Class I
- VIVE — VIVE HEALTH LLC · Class I
- Push braces — Nea International B.V. · Class I
- MedSource Extrication Device — MEDSOURCE INTERNATIONAL LLC · Class I
- Walgreens — WALGREEN CO. · Class I
- Cervical Collar — Dynarex Corp. · Class I
- MedSource Extrication Collar — MEDSOURCE INTERNATIONAL LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Flamor Srl
Sources (1)
- FDA UDI 18fb6644-d035-4a90-8655-72eee080baf4 32 fields · synced Jul 21, 2026