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

Tubing, Noninvasive (GAZ) (5) Drape, Surgical (KKX) (2) Container, Specimen, Non-Sterile (NNI) (1) Set, Administration, Intravascular (FPA) (1) Tube, Aspirating, Flexible, Connecting (BYY) (1)

Premarket Exempt

No Yes

Clear

Custom Medical Specialties, Inc. - 00815849021419 Catalog Number :

Device Description : 30' Tubing with M/F Luer-Lock - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BYY

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849021433 Catalog Number :

Device Description : Spring Loaded Syringe Delivery Kit - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849021457 Catalog Number :

Device Description : 12" Extension Set M/F LL - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849021471 Catalog Number :

Device Description : 36" Low Pressure Extension Set - Non-Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849021495 Catalog Number :

Device Description : 36" Low Pressure Extension Set - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849021518 Catalog Number :

Device Description : 20" Low Pressure Extension Set - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849021532 Catalog Number :

Device Description : 20" LS Extension Set - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849021556 Catalog Number :

Device Description : Sharps Collection System - Non-Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : NNI

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849021570 Catalog Number :

Device Description : Minor Procedure Drape w/ 2.75" Fenestration Box - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849021594 Catalog Number :

Device Description : Dome Cover 18" Depth - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

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