Cristcot LLC

Address:9 Damonmill Square, Suite 4A,Concord,MA,01742,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

Applicator For Rectal Suppository (OOW) (7) Applicator, Vaginal (HGD) (2)

Premarket Exempt

Yes No

Clear

Sephure® suppository applicator - 00850325006320 Catalog Number :

Device Description : size 0 capsule suppository applicator, single

Device Class : 1

Duns Number: 080739421

Premarket Exempt : Yes

Product Code : HGD

Prescription Use : No

Device Count : 1

Synalax - 00850325006405 Catalog Number :

Device Description : Synalax 3 pack with 3 Sephure suppository applicators

Device Class : 1

Duns Number: 080739421

Premarket Exempt : No

Product Code : OOW

Prescription Use : No

Device Count : 3

Sephure® suppository applicator - 00850325006429 Catalog Number :

Device Description : size 0 capsule suppository applicator, 6 total

Device Class : 1

Duns Number: 080739421

Premarket Exempt : Yes

Product Code : OOW, HGD

Prescription Use : No

Device Count : 6

Sephure® suppository applicator - 00868648000000 Catalog Number :

Device Description : A2 - rectal suppository applicator (individually wrapped)

Device Class : 1

Duns Number: 080739421

Premarket Exempt : No

Product Code : OOW

Prescription Use : No

Device Count : 1

Sephure® suppository applicator - 00868648000017 Catalog Number :

Device Description : B3 - rectal suppository applicator (individually wrapped)

Device Class : 1

Duns Number: 080739421

Premarket Exempt : No

Product Code : OOW

Prescription Use : No

Device Count : 1

Sephure® suppository applicator - 00868648000031 Catalog Number :

Device Description : A2 10-pouch - rectal suppository applicator, USA

Device Class : 1

Duns Number: 080739421

Premarket Exempt : No

Product Code : OOW

Prescription Use : No

Device Count : 10

Sephure® suppository applicator - 00868648000048 Catalog Number :

Device Description : B3 - rectal suppository applicator (individually wrapped)

Device Class : 1

Duns Number: 080739421

Premarket Exempt : No

Product Code : OOW

Prescription Use : No

Device Count : 10

Sephure® suppository applicator - 00868648000055 Catalog Number :

Device Description : A2 30-pouch - rectal suppository applicator, USA

Device Class : 1

Duns Number: 080739421

Premarket Exempt : No

Product Code : OOW

Prescription Use : No

Device Count : 30

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