FDA.reportPublic FDA data

Custom Medical Specialties, Inc.

Primary DI
00815849024571
Brand
Custom Medical Specialties, Inc.
Company
CUSTOM ASSEMBLIES, INC.
Model
CMS-6314-R6
Device description
Procedure Kit
Published
2023-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LROGeneral Surgery Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815849024571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815849024571008158490245718158490245710815849024571

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
948904735
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
00815849023369Custom Medical Specialties, Inc. CMS-12352023-09-13
00815849023390Custom Medical Specialties, Inc. CMS-12382023-09-13
00815849023406PG-1000PG-10002023-09-13
00815849023437Custom Assemblies, Inc. CMS-2012-R32023-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956544017CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956549760CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956560765CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956566613CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956569966CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956575868CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956587267CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956590533CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956592476CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956598126CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956599550CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956601758CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956604209CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956606623CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10653160394327MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160394334MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160394488MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160394617MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160394969MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160394983MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160395027MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160395171MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160395188MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160395294MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10809160540657HalyardAVID MEDICAL, INC.LRO2026-10-15
10885632540639SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-10-15
10885632540646SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-10-15
10653160395287MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-14
10653160395324MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-14
10653160395416MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-14