YOUNG MYDENT, 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

Gown, Examination (FME) (8) Wrap, Sterilization (FRG) (2)

Premarket Exempt

No Yes

Clear

Defend - 90816577021187 Catalog Number :

Device Description : DEFEND PLUS JACKET PINK LARGE

Device Class : 1

Duns Number: 081330555

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

Defend - 90816577021200 Catalog Number :

Device Description : DEFEND PLUS JACKET PINK MEDIUM

Device Class : 1

Duns Number: 081330555

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

Defend - 90816577021224 Catalog Number :

Device Description : DEFEND PLUS JACKET PINK SMALL

Device Class : 1

Duns Number: 081330555

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

Defend - 90816577021248 Catalog Number :

Device Description : DEFEND PLUS JACKET PURPLE LARGE

Device Class : 1

Duns Number: 081330555

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

Defend - 90816577021262 Catalog Number :

Device Description : DEFEND PLUS JACKET PURPLE MEDIUM

Device Class : 1

Duns Number: 081330555

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

Defend - 90816577021286 Catalog Number :

Device Description : DEFEND PLUS JACKET PURPLE SMALL

Device Class : 1

Duns Number: 081330555

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

Defend - 90816577021309 Catalog Number :

Device Description : DEFEND PLUS JACKET SKY BLUE LARGE

Device Class : 1

Duns Number: 081330555

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

Defend - 90816577021323 Catalog Number :

Device Description : DEFEND PLUS JACKET SKY BLUE MEDIUM

Device Class : 1

Duns Number: 081330555

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

Defend - 90816577021361 Catalog Number :

Device Description : STERI-POUCHES DEFEND+ 2.25'' X 4''

Device Class : 2

Duns Number: 081330555

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 1

Defend - 90816577021385 Catalog Number :

Device Description : STERI-POUCHES DEFEND+ 2 1/4'' X 2 2/3''

Device Class : 2

Duns Number: 081330555

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 1

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