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) (8) Drape, Surgical (KKX) (2)

Premarket Exempt

No Yes

Clear

Custom Medical Specialties, Inc. - 00815849022218 Catalog Number :

Device Description : 86" x 135" 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. - 00815849022232 Catalog Number :

Device Description : 36" Console Cover - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849022256 Catalog Number :

Device Description : Polyvinyl Urological Drainage Bag for Siemens Systems - Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849022270 Catalog Number :

Device Description : Vinyl Acetate Urological Drainage Bag for Siemens Systems - Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849022294 Catalog Number :

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

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849022317 Catalog Number :

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

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849022324 Catalog Number :

Device Description : Polyvinyl Urological Drainage Bag 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. - 00815849022348 Catalog Number :

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

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849022362 Catalog Number :

Device Description : Vinyl Acetate Urological Drainage Bag 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. - 00815849022386 Catalog Number :

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

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

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