Medical device shortage: Dia-100FS Regular Set

The Dia-100FS Regular Set 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 2020-06-01

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

Dia-100FS Regular Set

Other names (for example trade name), if applicable

Face Shield

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

5 face shields and 1 frame

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)

1005-5011

Medical device licence number (for Class II, III and IV), if known

n/a

Single use product

Manufacturer’s name

DiaDent Group International Inc.

Manufacturer’s mailing address

16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu
Cheongju-si
Chungcheongbuk-do
Korea
28161

Reason for shortage

Disruption of the manufacturing of a medical device

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