FDA.report

Custom Medical Specialties, Inc.

Primary DI
00815849025103
Brand
Custom Medical Specialties, Inc.
Company
CUSTOM ASSEMBLIES, INC.
Model
CMS-8387-R1
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
00815849025103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815849025103008158490251038158490251030815849025103

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

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