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) (2) Drape, Surgical (KKX) (2) Tubing, Pressure And Accessories (BYX) (2) Tubing, Noninvasive (GAZ) (1) Table And Attachments, Operating-Room (BWN) (1) Adaptor, Catheter (GCE) (1) Tube, Aspirating, Flexible, Connecting (BYY) (1)

Premarket Exempt

No Yes

Clear

Custom Medical Specialties, Inc. - 00815849022966 Catalog Number :

Device Description : Custom Tumescent Set - Non-Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849022980 Catalog Number :

Device Description : Custom Tubing 48" Extension Set - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849023000 Catalog Number :

Device Description : Urological Drainbag w/ 6mm Plug for Skytron Systems- Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849023024 Catalog Number :

Device Description : Short Expandable Hose - Non-Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : No

Device Count : 1

Custom Medical Specialties - 00815849023048 Catalog Number :

Device Description : 72" Drainage Hose - Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849023062 Catalog Number :

Device Description : US Probe Cover, Rolled 5" x 93" - Sterile

Device Class :

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849023086 Catalog Number :

Device Description : Instillation (BCG) Kit - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BYY

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849023109 Catalog Number :

Device Description : 5" x 12" Band Bag - Non-Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849023116 Catalog Number :

Device Description : 3" IV Transfer Connecting Set - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849023130 Catalog Number :

Device Description : Catheter Adapter - Sterile

Device Class :

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : GCE

Prescription Use : No

Device Count : 1

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