FDA.report

Custom Medical Specialties, Inc.

Primary DI
00815849024441
Brand
Custom Medical Specialties, Inc.
Company
CUSTOM ASSEMBLIES, INC.
Model
CMS-235-2
Device description
Procedure Kit
Published
2023-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LROGeneral Surgery Tray

Product Code Classifications

CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815849024441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815849024441008158490244418158490244410815849024441

GMDN Terms

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

Regulatory Flags

DUNS number
948904735
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
00815849023437Custom Assemblies, Inc. CMS-2012-R32023-09-13
00815849023444Custom Assemblies, Inc. CMS-8322-R12023-09-13
00815849023451Custom Medical Specialties, Inc. CMS-5650-R22023-09-13
00815849023468Custom Medical Specialties, Inc. CMS-63822023-09-13
00815849023475Custom Medical Specialties, Inc. CMS-6439-C2023-09-13
00815849023482MPMMPM-312-R12023-09-13
00815849023499Custom Medical Specialties, Inc. CMS-1911-R32023-09-13
00815849023505MPMMPM-2952023-09-13
00815849023512Custom Medical Specialties, Inc. CMS-2450-R42023-09-13
00815849023529Custom Medical Specialties, Inc. CMS-4439-R52023-09-13
00815849023536Custom Medical Specialties, Inc. CMS-6803-R12023-09-13
00815849023543Custom Medical Specialties, Inc. CMS-8963-R12023-09-13
00815849023550Custom Medical Specialties, Inc. CMS-6415-R12023-09-13
00815849023567Custom Medical Specialties, Inc. CMS-8522-R22023-09-13
00815849023574Custom Medical Specialties, Inc. CMS-4028-R52023-09-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50198956219043CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956300116CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956306866CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956327939CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956334760CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956359893CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956379167CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956379211CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956382150CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956391329CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956391541CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956392616CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956392890CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956394542CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956399073CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956414585CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956414806CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956415230CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956415926CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956416862CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956419788CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956425376CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956427493CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956427677CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956428926CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
20809160517243HalyardAVID MEDICAL, INC.LRO2026-03-24
20809160517250HalyardAVID MEDICAL, INC.LRO2026-03-24
50198956157550CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-23
50198956220742CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-23
50198956273168CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-23