Home GUDID 00815849022072 Custom Medical Specialties, Inc.
Primary DI 00815849022072
Brand Custom Medical Specialties, Inc.
Company CUSTOM ASSEMBLIES, INC.
Model CMS-7101
Device description Custom HSG Catheter - Sterile
Published 2016-11-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Sterile true
Single use true Product Codes# Code, Name table Code Name GBA Catheter, Balloon Type
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GBA Catheter, Balloon Type General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00815849022089 Package GS1 10 In Commercial Distribution 00815849022072 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00815849022089 00815849022089 815849022089 0815849022089 00815849022072 00815849022072 815849022072 0815849022072
GMDN Terms# Term, Definition table Term Definition Indwelling urethral drainage balloon catheter, non-antimicrobial A flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage; it might also be designed for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.
Regulatory Flags# DUNS number 948904735 Device count 1 Premarket exempt true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00815849020160 Custom Medical Specialties, Inc. CMS-510 2016-11-21 00815849020177 Custom Medical Specialties, Inc. CMS-515 2016-11-21 00815849021556 Custom Medical Specialties, Inc. CMS-1637-NS 2016-11-21 00815849021839 Custom Medical Specialties, Inc. CMS-586 2016-11-21 00815849024021 Custom Medical Specialties, Inc. CMS-2732-R4 2023-09-14 00815849024571 Custom Medical Specialties, Inc. CMS-6314-R6 2023-09-14 00815849023369 Custom Medical Specialties, Inc. CMS-1235 2023-09-13 00815849023390 Custom Medical Specialties, Inc. CMS-1238 2023-09-13 00815849023406 PG-1000 PG-1000 2023-09-13 00815849023437 Custom Assemblies, Inc. CMS-2012-R3 2023-09-13 00815849023444 Custom Assemblies, Inc. CMS-8322-R1 2023-09-13 00815849023451 Custom Medical Specialties, Inc. CMS-5650-R2 2023-09-13 00815849023468 Custom Medical Specialties, Inc. CMS-6382 2023-09-13 00815849023475 Custom Medical Specialties, Inc. CMS-6439-C 2023-09-13 00815849023482 MPM MPM-312-R1 2023-09-13 00815849023499 Custom Medical Specialties, Inc. CMS-1911-R3 2023-09-13 00815849023505 MPM MPM-295 2023-09-13 00815849023512 Custom Medical Specialties, Inc. CMS-2450-R4 2023-09-13 00815849023529 Custom Medical Specialties, Inc. CMS-4439-R5 2023-09-13 00815849023536 Custom Medical Specialties, Inc. CMS-6803-R1 2023-09-13
Other Devices Sharing Product Codes#