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Novalite 16-100FOMD-Mac 1

by Novamed-USA

Novalite 16-100FOMD-Mac 1 is a laryngoscope blade (FDA Class I; FDA product code CCW, Laryngoscope, Rigid) made by Novamed-USA, listed in FDA GUDID since 27 Jun 2023 (UDI-DI 00817499020743), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817499020743 UDI-DI Date27 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Novalite
Generic name
Laryngoscope blade, single-use
Model / reference
16-100FOMD-MAC 1
Description
SINGLE USE FO HYBRID SS WITH ACRYLIC FO BUNDLE MAC 1 LARYNGOSCOPE BLADE
Primary DI / UDI-DI
00817499020743
FDA product code
CCW
GMDN term
Laryngoscope blade, single-use
Device class
Class I
Regulation number
868.5540
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Laryngoscope blade, single-use

Similar devices in this category

Other devices filed under Laryngoscope blade, single-use.

Other devices from Novamed-USA

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Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)