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

Drape, Surgical (KKX) (5) Tubing, Noninvasive (GAZ) (2) Applicator, Absorbent Tipped, Sterile (KXG) (1) Needle, Aspiration And Injection, Disposable (GAA) (1) Speculum, Vaginal, Nonmetal (HIB) (1)

Premarket Exempt

No Yes

Clear

Custom Medical Specialties, Inc. - 00815849021617 Catalog Number :

Device Description : 20" 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. - 00815849021631 Catalog Number :

Device Description : 20" x 15" BandBag - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849021655 Catalog Number :

Device Description : 20" x 36" Foot-switch Cover - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849021679 Catalog Number :

Device Description : Small Vaginal Speculum - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : HIB

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849021693 Catalog Number :

Device Description : 21GA x 2" Needle - Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849021716 Catalog Number :

Device Description : 48" 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. - 00815849021730 Catalog Number :

Device Description : 30" x 30" BandBag - Non-Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849021754 Catalog Number :

Device Description : 30" x 36" BandBag - Non-Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849021778 Catalog Number :

Device Description : 36" x 28" BandBag - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849021792 Catalog Number :

Device Description : 10.5 mL Teal Chloraprep - Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : No

Device Count : 1

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