FDA.reportPublic FDA data

Custom Assemblies, Inc.

Primary DI
00815849023437
Brand
Custom Assemblies, Inc.
Company
CUSTOM ASSEMBLIES, INC.
Model
CMS-2012-R3
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
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
00815849023437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815849023437008158490234378158490234370815849023437

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
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
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

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