IRONWEAR

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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

Gown, Surgical (FYA) (4) Mask, Surgical (FXX) (2) Thermometer, Electronic, Clinical (FLL) (1)

Premarket Exempt

Clear

ironwear - 00607659524217 Catalog Number :

Device Description : Surgical Gown, level 4, size MD

Device Class : 2

Duns Number: 060015430

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

ironwear - 00607659524224 Catalog Number :

Device Description : Surgical Gown, level 4, size LG

Device Class : 2

Duns Number: 060015430

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

ironwear - 00607659524231 Catalog Number :

Device Description : Surgical Gown, level 4, size XL

Device Class : 2

Duns Number: 060015430

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

ironwear - 00607659524248 Catalog Number :

Device Description : Surgical Gown, level 4, size 2XL

Device Class : 2

Duns Number: 060015430

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

ironwear - 10607659150314 Catalog Number :

Device Description : Surgical 3 ply face mask

Device Class : 2

Duns Number: 060015430

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

ironwear - 10607659150413 Catalog Number :

Device Description : Surgical 3 ply face mask

Device Class : 2

Duns Number: 060015430

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

ironwear - 10607659787206 Catalog Number :

Device Description : Digital Thermometer

Device Class : 2

Duns Number: 060015430

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

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