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Necklite

FDA UDI

Class I (US FDA UDI)

by Flamor Srl

Identity

Trade Name
NECKLITE FDA UDI
Generic Name
Cervical spine collar, reusable FDA UDI
Model / Reference
BLK FDA UDI

Identifiers

Primary DI / UDI-DI
08057592700131 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

Necklite by Flamor Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cervical spine collar, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Flamor Srl

Sources (1)

  • FDA UDI 4184d84a-12c0-4f2c-814c-b16c28eed002 32 fields · synced May 30, 2026