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) Forceps, General & Plastic Surgery (GEN) (1) Tube, Aspirating, Flexible, Connecting (BYY) (1)

Premarket Exempt

No Yes

Clear

Custom Medical Specialties, Inc. - 00815849022607 Catalog Number :

Device Description : Polyvinyl Urological Drainage Bag for GE/OEC Systems w/ 10mm 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. - 00815849022621 Catalog Number :

Device Description : Vinyl Acetate 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. - 00815849022645 Catalog Number :

Device Description : Polyvinyl Urological Drainage Bag for Skytron Systems w/ 10mm 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. - 00815849022669 Catalog Number :

Device Description : Vinyl Acetate 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

Custom Medical Specialties, Inc. - 00815849022683 Catalog Number :

Device Description : Vinyl Acetate Urological Drainage Bag for Dornier 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. - 00815849022706 Catalog Number :

Device Description : Polyvinyl Urological Drainage Bag 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. - 00815849022720 Catalog Number :

Device Description : Universal Urological Drainage Bag 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. - 00815849022843 Catalog Number :

Device Description : Universal Urological Drainbag w/ 12"x12" 2ml Vented Polybag - Non-Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849022867 Catalog Number :

Device Description : Halstead Mosquito Forcep - Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849022928 Catalog Number :

Device Description : Urology Tubing Set - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BYY

Prescription Use : No

Device Count : 1

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