CUSTOM ASSEMBLIES, INC.

Address:330 EAST MAIN STREET,PINE LEVEL,NC,27568,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

Set, Administration, Intravascular (FPA) (7) Tubing, Noninvasive (GAZ) (2) Tube, Aspirating, Flexible, Connecting (BYY) (1)

Premarket Exempt

No Yes

Clear

Custom Medical Specialties, Inc. - 00815849020009 Catalog Number :

Device Description : Tumescent Hand Pump Set - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849020016 Catalog Number :

Device Description : Contrast Transfer Set - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849020023 Catalog Number :

Device Description : Single Spike Tumescent Set - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849020030 Catalog Number :

Device Description : Single Spike Tumescent Set - Non-Sterile

Device Class :

Duns Number: 948904735

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849020047 Catalog Number :

Device Description : Single Spike Tumescent Set w/o Chamber - Sterile

Device Class :

Duns Number: 948904735

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849020054 Catalog Number :

Device Description : Single Spike Tumescent Set w/o Chamber - Non-Sterile

Device Class :

Duns Number: 948904735

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849020061 Catalog Number :

Device Description : Fluid Control System - Non-Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BYY

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849020078 Catalog Number :

Device Description : 108" Transition Tubing - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849020085 Catalog Number :

Device Description : 60" Coiled Injection Line - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849020092 Catalog Number :

Device Description : 72" Coiled Injection Line - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

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