Novalite

FDA UDI

Class I (US FDA UDI)

by Novamed-Usa

Identity

Trade Name: NOVALITE FDA UDI
Generic Name: Laryngoscope blade, single-use FDA UDI
Device Name: SINGLE USE FO HYBRID SS WITH ACRYLIC FO BUNDLE MAC 4 LARYNGOSCOPE BLADE FDA UDI
Model / Reference: 16-100FOMD-MAC 4 FDA UDI
Description: SINGLE USE FO HYBRID SS WITH ACRYLIC FO BUNDLE MAC 4 LARYNGOSCOPE BLADE FDA UDI

Identifiers

Primary DI / UDI-DI: 00817499020774 FDA UDI
FDA Product Code: CCW FDA UDI
GMDN Term: Laryngoscope blade, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Laryngoscope blade, single-use

Novalite by Novamed-Usa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laryngoscope blade, single-use.

BriteBlade Pro Single-Use Fiber Optic Robertshaw 0 — FLEXICARE MEDICAL LIMITED · Class I
Vital Signs™ — VYAIRE MEDICAL, INC. · Class I
Medline — MEDLINE INDUSTRIES, INC. · Class I
IntuBrite Sterile — SALTER LABS · Class I
SunMed — SunMed · Class I
RUSCH — TELEFLEX INCORPORATED · Class I
Disposable Conventional Laryngoscope Blade — Maco International · Class I
IntuBrite — SALTER LABS · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Novamed-Usa

Sources (1)

FDA UDI b86bf028-b6f3-4099-a0e1-56f26b4974b7 34 fields · synced Jun 7, 2026