Qyk Brands LLC

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Mask, Surgical (FXX) (3) Gown, Surgical (FYA) (1)

Premarket Exempt

Clear

1MED - 00850039859465 Catalog Number :

Device Description : 1MED Surgical Mask, Level 2, Earloop style non-sterile, single-use, 50ct Box

Device Class :

Duns Number: 081560441

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

1MED - 00850039859472 Catalog Number :

Device Description : 1MED Surgical Mask, Level 3, Earloop style non-sterile, single-use, 50ct Box

Device Class :

Duns Number: 081560441

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

1MED - 00850039859502 Catalog Number :

Device Description : 1MED Surgical Mask, Level 1, Earloop style non-sterile, single-use, 50ct Box

Device Class :

Duns Number: 081560441

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

1MED - 10850027748846 Catalog Number :

Device Description : 1MED Disposable Surgical Gown, Large, sterile

Device Class : 2

Duns Number: 081560441

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

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