MAYTEX CORPORATION

Address:23521 FOLEY ST.,HAYWARD,CA,94545,US

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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

Non-Surgical Isolation Gown (OEA) (10)

Premarket Exempt

No Yes

Clear

Maytex - D8066000W2 Catalog Number :

Device Description : Isolation gown with elastic cuff white

Device Class : 1

Duns Number: 196642151

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 50

Maytex - D8066000Y2 Catalog Number :

Device Description : Isolation gown with elastic cuff yellow

Device Class : 1

Duns Number: 196642151

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 50

Maytex - D8066010BC2 Catalog Number :

Device Description : Isolation Gown with knit cuff, blue

Device Class : 1

Duns Number: 196642151

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 50

Maytex - D8066010BCXL2 Catalog Number :

Device Description : Isolation gown with knit cuff blue XL

Device Class : 1

Duns Number: 196642151

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 50

Maytex - D8066010GC2 Catalog Number :

Device Description : Isolation gown with knit cuff green

Device Class : 1

Duns Number: 196642151

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 50

Maytex - D8066010PC2 Catalog Number :

Device Description : Isolation gown with knit cuff pink

Device Class : 1

Duns Number: 196642151

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 50

Maytex - D8066010WC2 Catalog Number :

Device Description : Isolation gown with knit cuff white

Device Class : 1

Duns Number: 196642151

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 50

Maytex - D8066010YC2 Catalog Number :

Device Description : Isolation gown with knit cuff yellow

Device Class : 1

Duns Number: 196642151

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 50

Maytex - D8066012BC2 Catalog Number :

Device Description : AAMI level 2 isolation gown blue

Device Class : 1

Duns Number: 196642151

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 50

Maytex - D8066012WC2 Catalog Number :

Device Description : AAMI Level 2 isolation gown white

Device Class : 1

Duns Number: 196642151

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 50

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