Medical device shortage: Ultra Sensitive Earloop Mask with SecureFit Mask Technology

The Ultra Sensitive Earloop Mask with SecureFit Mask Technology is currently reported as a medical device shortage through the Interim Order to help prevent or alleviate shortages in relation to COVID-19. For a full list of shortages, refer to the medical device shortages: list of shortages.

Posted on June 15, 2020

Type of report

Actual medical device shortage

Name of medical device (including any component, accessory, consumable material or part that is in shortage, including the model name) if applicable

Ultra Sensitive Earloop Mask with SecureFit Mask Technology

Other names (for example trade name), if applicable

n/a

Package description (for example, packaging formats, sizes, quantities)

50 masks per box, 10 boxes per carton, 4 cartons per case

Class of medical device (I, II, III or IV), if known

Class I

Device identifier(s) (for example, serial number, catalogue number, part number, model number, or unique device identifier)
  • UDI#: 10732224120062
  • Model # GCFCXSSF
Medical device licence number (for Class II, III and IV), if known

n/a

Single use product

Yes

Importers that have reported the shortage (Names of importers listed who have reported the shortage separately from the manufacturer or who are reporting on behalf of the manufacturer in a delegated capacity), if applicable

Henry Schein Canada, Inc.

Manufacturer’s name

Crosstex International, Inc.

Manufacturer’s mailing address

10 Ranick Road
Hauppauge, New York
USA
11788

Reason for shortage
  • Increase in demand for the medical device

  • Export restrictions

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