IRONWEAR

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) (10)

Premarket Exempt

No

Clear

ironwear - 00607659524019 Catalog Number :

Device Description : Surgical Gown, level 3, size MD

Device Class : 2

Duns Number: 060015430

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

ironwear - 00607659524026 Catalog Number :

Device Description : Surgical Gown, level 3, size LG

Device Class : 2

Duns Number: 060015430

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

ironwear - 00607659524033 Catalog Number :

Device Description : Surgical Gown, level 3, size XL

Device Class : 2

Duns Number: 060015430

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

ironwear - 00607659524040 Catalog Number :

Device Description : Surgical Gown, level 3, size 2XL

Device Class : 2

Duns Number: 060015430

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

ironwear - 00607659524118 Catalog Number :

Device Description : Surgical Gown, level 3, size SM

Device Class : 2

Duns Number: 060015430

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

ironwear - 00607659524125 Catalog Number :

Device Description : Surgical Gown, level 3, size MD

Device Class : 2

Duns Number: 060015430

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

ironwear - 00607659524132 Catalog Number :

Device Description : Surgical Gown, level 3, size LG

Device Class : 2

Duns Number: 060015430

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

ironwear - 00607659524149 Catalog Number :

Device Description : Surgical Gown, level 3, size XL

Device Class : 2

Duns Number: 060015430

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

ironwear - 00607659524156 Catalog Number :

Device Description : Surgical Gown, level 3, size 2XL

Device Class : 2

Duns Number: 060015430

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

ironwear - 00607659524200 Catalog Number :

Device Description : Surgical Gown, level 4, size SM

Device Class : 2

Duns Number: 060015430

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

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