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

Table And Attachments, Operating-Room (BWN) (10)

Premarket Exempt

No Yes

Clear

Custom Medical Specialties, Inc. - 00815849020306 Catalog Number :

Device Description : Vinyl Acetate Urological Drainage Bag for Siemens Systems w/ XL Hose - Non-Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849020313 Catalog Number :

Device Description : Vinyl Acetate Urological Drainage Bag for Liebel/OEC Systems - Non-Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849020320 Catalog Number :

Device Description : Vinyl Acetate Urological Drainage Bag for Liebel/OEC Systems w/ 8mm Plug - Non-Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849020337 Catalog Number :

Device Description : Polyvinyl Urological Drainage Bag for GE/OEC Systems - Non-Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849020344 Catalog Number :

Device Description : Polyvinyl Urological Drainage Bag for GE/OEC Systems w/ 6mm Plug - Non-Sterile

Device Class :

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849020351 Catalog Number :

Device Description : Polyvinyl Urological Drainage Bag for GE/OEC Systems w/ 8mm Plug - Non-Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849020368 Catalog Number :

Device Description : Vinyl Acetate Urological Drainage Bag for GE/OEC Systems - Non-Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849020375 Catalog Number :

Device Description : Polyvinyl Urological Drainbag for Skytron Systems - Non-Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849020382 Catalog Number :

Device Description : Polyvinyl Urological Drainage Bag for Skytron Systems w/ 6mm Plug - Non-Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849020399 Catalog Number :

Device Description : Polyvinyl Urological Drainage Bag for Skytron Systems w/ 8mm Plug - Non-Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

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