FDA.report

Custom Medical Specialties, Inc.

Primary DI
00815849020757
Brand
Custom Medical Specialties, Inc.
Company
CUSTOM ASSEMBLIES, INC.
Model
CMS-6025-NS
Device description
Absorbent Pad - Non-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
false
Single use
true

Related Records

Product Codes

CodeName
FRLFiber, Medical, Absorbent

Product Code Classifications

CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815849020757PackageGS125In Commercial Distribution
00815849020184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815849020757008158490207578158490207570815849020757
00815849020184008158490201848158490201840815849020184

GMDN Terms

TermDefinition
Absorbent underpadA flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures, childbirth and/or incontinence. It is intended to be used in the healthcare facility and in the home. This is a single-use device.

Sterilization Methods

Method
Ethylene Oxide

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
true
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
true

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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