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MolecuLight DarkDrape 1426

by MolecuLight Inc

MolecuLight DarkDrape 1426 is a patient surgical drape (FDA Class II; FDA product code PUI, Drape, Surgical, Exempt) made by MolecuLight Inc, listed in FDA GUDID since 5 Jan 2022 (UDI-DI 00628110259295), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00628110259295 UDI-DI Date5 Jan 2022ListedStatusListed 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  • Withdrawn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
MolecuLight DarkDrape
Generic name
Patient surgical drape, single-use
Model / reference
1426
Primary DI / UDI-DI
00628110259295
FDA product code
PUI
GMDN term
Patient surgical drape, single-use
Device class
Class II
Regulation number
878.4370
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code PUI (Drape, Surgical, Exempt).

Other devices from MolecuLight Inc

See all devices from MolecuLight Inc →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)