FDA.report

Custom Medical Specialties, Inc.

Primary DI
00815849021860
Brand
Custom Medical Specialties, Inc.
Company
CUSTOM ASSEMBLIES, INC.
Model
CMS-5896
Device description
Label Pack - Sterile
Published
2016-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LYVLabel Or Tag, Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
LYVLabel Or Tag, SterileGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815849021860PackageGS150In Commercial Distribution
00815849021853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815849021860008158490218608158490218600815849021860
00815849021853008158490218538158490218530815849021853

GMDN Terms

TermDefinition
Sterility label/tagA label or tag designed for use prior to, during, and after the process of sterilization of the device it has been attached to for the purpose of indicating that the sterility level required has been achieved. This label/tag can be designed with various built-in indicators that show if the sterility level has been reached or not, e.g., a change in the colour of the label/tag. 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
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
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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