FDA.reportPublic FDA data

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
CodeName
GBACatheter, Balloon Type

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBACatheter, Balloon TypeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815849022089PackageGS110In Commercial Distribution
00815849022072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815849022089008158490220898158490220890815849022089
00815849022072008158490220728158490220720815849022072

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral drainage balloon catheter, non-antimicrobialA 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 DIBrandModelCatalogPublished
00815849021556Custom Medical Specialties, Inc.CMS-1637-NS2016-11-21
00815849021839Custom Medical Specialties, Inc.CMS-5862016-11-21
00815849020917Custom Medical Specialties, Inc.CMS-9872026-10-06
00815849022768Custom Medical Specialties, Inc.CMS-9072026-10-06
00815849022775Custom Medical Specialties, Inc.CMS-910V2026-10-06
00815849022782Custom Medical Specialties, Inc.CMS-912V2026-10-06
00815849022836Custom Medical Specialties, Inc.CMS-919VT2026-10-06
00815849025288Custom Medical Specialties, Inc.CMS-3002026-10-06
00815849025363Custom Medical Specialties, Inc.CMS-20102026-10-06
00815849025493Custom Medical Specialties, Inc.CMS-954V-62026-10-06
00815849025615Custom Medical Specialties, Inc.CMS-9092026-10-06
00815849025844Custom Medical Specialties, Inc.CMS-942V2026-10-06
00815849020160Custom Medical Specialties, Inc.CMS-5102016-11-21
00815849020177Custom Medical Specialties, Inc.CMS-5152016-11-21
00815849020108Custom Medical Specialties, Inc.CMS-16372016-11-21
00815849024021Custom Medical Specialties, Inc. CMS-2732-R42023-09-14
00815849024571Custom Medical Specialties, Inc. CMS-6314-R62023-09-14
00815849023369Custom Medical Specialties, Inc. CMS-12352023-09-13
00815849023390Custom Medical Specialties, Inc. CMS-12382023-09-13
00815849023406PG-1000PG-10002023-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04026704916955RUSCHTELEFLEX INCORPORATEDGBA2026-08-03
00860014541704EnvisionSPINAL STABILIZATION TECHNOLOGIES LIMITEDGBA2026-04-30
00860014541711EnvisionSPINAL STABILIZATION TECHNOLOGIES LIMITEDGBA2026-04-30
06979032640031GOBENHUZHOU JUNDA INDUSTRY CO., LTD.GBA2025-08-26
M7403150006VerifySPINEOLOGY INC.GBA2023-06-26
00887482173718Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.GBA2022-09-21
00678467004963 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467005007 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467005847 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467005915 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467006134 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467006547 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467006677 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467006707 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467006868 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467506184 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467506252 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467506276 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467506337 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467506610 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467001450Mui ScientificH & A Mui Enterprises IncGBA2019-10-16
00678467001627 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467001894 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467001924 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467002150 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467002358 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467002426 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467002549 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467002600 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467002655 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16