WINCHESTER LABORATORIES LLLP

Address:301 W. Atlantic Avenue,Delray Beach,FL,33444,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

Dressing, Wound, Drug (FRO) (2)

Premarket Exempt

Clear

Saljet - 10188151000005 Catalog Number :

Device Description : Saljet 40 is a single use disposable polymer vial with a twist off top containin Saljet 40 is a single use disposable polymer vial with a twist off top containing 30ml of sterile normal saline 0.9% w/v. It contains no preservatives, surfactants or buffering. The vials are packed into an outer shelf carton. Forty vials per carton.

Device Class :

Duns Number: 038838914

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 40

Saljet - 20188151000002 Catalog Number :

Device Description : Saljet 6 is a single use disposable polymer vial with a twist off top containing Saljet 6 is a single use disposable polymer vial with a twist off top containing 30ml of sterile normal saline 0.9% w/v. It contains no preservatives, surfactants or buffering. The vials are packed into an outer shelf carton. six vials per carton.

Device Class :

Duns Number: 038838914

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 6

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