Home GUDID 00815849024861 Custom Medical Specialties, Inc.
Primary DI 00815849024861
Brand Custom Medical Specialties, Inc.
Company CUSTOM ASSEMBLIES, INC.
Model CMS-6135-R1
Device description Procedure Kit
Published 2023-09-13
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Sterile true
Single use true Product Codes# Code, Name table Code Name LRO General Surgery Tray
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LRO General Surgery Tray General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00815849024861 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 00815849024861 00815849024861 815849024861 0815849024861
GMDN Terms# Term, Definition table Term Definition General surgical procedure kit, non-medicated, single-use A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.
Regulatory Flags# DUNS number 948904735 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label 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# Primary DI, Brand, Company table Primary DI Brand Company Product code Published H65857029125 Henry Schein HENRY SCHEIN, INC. LRO 2022-02-09 H65857029135 Henry Schein HENRY SCHEIN, INC. LRO 2022-02-09 H65857029145 Henry Schein HENRY SCHEIN, INC. LRO 2022-02-09 H65857029165 Henry Schein HENRY SCHEIN, INC. LRO 2022-02-09 H65857029105 Henry Schein HENRY SCHEIN, INC. LRO 2022-02-08 H65857029115 Henry Schein HENRY SCHEIN, INC. LRO 2022-02-08 H65857029095 Henry Schein HENRY SCHEIN, INC. LRO 2022-02-04 H65857029005 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-31 H65857028265 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-28 H65857028255 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-27 H65857028285 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-27 H65857029045 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-27 H65857029055 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-27 H65857029065 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-27 H65857029075 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-27 H65857029085 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-27 H65857028925 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-26 H65857028935 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-25 H65857028945 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-25 H65857028915 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-24 H65857028965 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-24 H65857028975 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-24 H65857028985 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-24 H65857028995 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-24 H65857029015 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-24 H65857028905 Henry Schein HENRY SCHEIN, INC. LRO 2022-01-18 H65857028875 Henry Schein HENRY SCHEIN, INC. LRO 2021-12-29 H65857028865 Henry Schein HENRY SCHEIN, INC. LRO 2021-12-21 H65857028855 Henry Schein HENRY SCHEIN, INC. LRO 2021-12-14 H65857028845 Henry Schein HENRY SCHEIN, INC. LRO 2021-12-13