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) (4) Applicator, Absorbent Tipped, Sterile (KXG) (2) Applicator, Absorbent Tipped, Non-Sterile (KXF) (1) Catheter, Balloon Type (GBA) (1) Clamp (HXD) (1) Pack, Hot Or Cold, Disposable (IMD) (1)

Premarket Exempt

No Yes

Clear

Custom Medical Specialties, Inc. - 00815849022010 Catalog Number :

Device Description : Instant Ice Pack - Non-Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : IMD

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849022034 Catalog Number :

Device Description : Angled Prep Stick - Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849022058 Catalog Number :

Device Description : Angled Prep Stick - Non-Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : KXF

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849022072 Catalog Number :

Device Description : Custom HSG Catheter - Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : GBA

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849022096 Catalog Number :

Device Description : Towel Clamp - Non-Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : HXD

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849022119 Catalog Number :

Device Description : Foam Prep Sticks - Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849022133 Catalog Number :

Device Description : Fan Folded Table Cover - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849022157 Catalog Number :

Device Description : 86" x 125" Femoral Drape - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849022171 Catalog Number :

Device Description : 6" x 96" Probe Cover w/ Bands and Gel - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849022195 Catalog Number :

Device Description : Procedure Drape - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

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