FDA.reportPublic FDA data

Rospital Productos Medicos

Primary DI
10812460028008
Brand
Rospital Productos Medicos
Company
ATLAS MEDICAL PRODUCTS LLC
Model
CP4403
Catalog number
CP4403
Device description
ORTHOPAEDIC CAST PADDING 100% COTTON - 4"X4 YARDS, EA.
Published
2020-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ITGBandage, Cast

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITGBandage, CastPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10812460028008PackageGS112In Commercial Distribution
20812460028005PackageGS16In Commercial Distribution
00812460028001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081246002800810812460028008
2081246002800520812460028005
00812460028001008124600280018124600280010812460028001

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose medical fibre paddingA roll, sheet or preformed shape of synthetic (e.g., polyester, polypropylene) or natural (e.g., cotton) fibre intended to be applied to and/or compress a local area of the body for various preventative/therapeutic applications (e.g., in compression bandaging, padding under casts and splints, padding for anatomical depressions), typically over intact and healthy skin. It is intended for use in the home or a clinical setting. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
786-473-9436levalenzuela17@gmail.com

Regulatory Flags#

DUNS number
013112308
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812460027035Rospital Productos MedicosSY10WNSY10WN2020-06-13
00812460027059Rospital Productos MedicosSY10215SY102152020-06-13
00812460020777Rospital Productos MedicosGS4021262022-10-21
00812460020821Rospital Productos MedicosCW500101CW5001012022-10-21
00812460021965Rospital Productos MedicosGS4021284021282022-10-21
00812460025086Rospital Productos MedicosGS402122GS4021222022-10-21
00812460028131Rospital Productos MedicosFM3501FM35012020-09-29
00812460020395ROSPITAL PRODUCTOS MEDICOSELSELS2024-08-23
10812460020392ROSPITAL PRODUCTOS MEDICOSELSELS2024-08-23
00812460021484ROSPITAL PRODUCTOS MEDICOSELSPELSP2024-08-23
00812460024799ROSPITAL PRODUCTOS MEDICOSESPWHESPWH2024-08-23
00812460024768Rospital Producos MedicosSY05WN31516SY05WN315162024-04-16
00812460024775Rospital Productos MedicosSY05WN32516SY05WN325162024-04-16
00812460024782Rospital Productos MedicosSY05WN3012SY05WN30122024-04-16
00812460026243Rospital Productos MedicosSY1WN32516SY1WN325162024-04-16
00812460026274Rospital Productos MedicosSY1WN3012SY1WN30122024-04-16
00812460026298Rospital Productos MedicosSY1WN31516SY1WN315162024-04-16
10812460024765Rospital Producos MedicosSY05WN31516SY05WN315162024-04-16
10812460024772Rospital Productos MedicosSY05WN32516SY05WN325162024-04-16
10812460024789Rospital Productos MedicosSY05WN3012SY05WN30122024-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
007073874969683M™3M Deutschland GmbHITG2026-05-08
007073874969753M™3M Deutschland GmbHITG2026-05-08
007073874969823M™3M Deutschland GmbHITG2026-05-08
007073874969993M™3M Deutschland GmbHITG2026-05-08
087114280529303M™ Scotchcast™Solventum US LLCITG2026-04-18
087114280529543M™ Scotchcast™Solventum US LLCITG2026-04-18
087114280529923M™ Scotchcast™Solventum US LLCITG2026-04-18
087114280530363M™ Scotchcast™Solventum US LLCITG2026-04-18
087114280530503M™ Scotchcast™Solventum US LLCITG2026-04-18
10080196284191MEDLINEMEDLINE INDUSTRIES, INC.ITG2026-01-22
10080196832330MEDLINEMEDLINE INDUSTRIES, INC.ITG2026-01-22
10192253045864WebrilCardinal Health 200, LLCITG2025-09-23
10192253045871WebrilCardinal Health 200, LLCITG2025-09-23
10192253045888WebrilCardinal Health 200, LLCITG2025-09-23
10192253045925WebrilCardinal Health 200, LLCITG2025-09-23
00840117344396"CurPro Undercast Padding , 100% Polyester, 3"" x 4 yd "Dynarex CorporationITG2025-06-05
00840117344402"CurPro Undercast Padding, 100% Polyester, 4"" x 4 yd "Dynarex CorporationITG2025-06-05
00840117344419"CurPro Undercast Padding, 100% Polyester, 6"" x 4 yd "Dynarex CorporationITG2025-06-05
00840117344426"CurPro Undercast Padding, 100% Polyester, 8"" x 4 yd"Dynarex CorporationITG2025-06-05
10885632106545MediChoiceOWENS & MINOR DISTRIBUTION, INC.ITG2025-01-16
10885632106514MediChoiceOWENS & MINOR DISTRIBUTION, INC.ITG2025-01-09
10885632106538MediChoiceOWENS & MINOR DISTRIBUTION, INC.ITG2025-01-09
10197106823019CARDINAL HEALTHCardinal Health 200, LLCITG2024-12-04
10080196745616MedlineMEDLINE INDUSTRIES, INC.ITG2023-10-13
10080196745661MedlineMEDLINE INDUSTRIES, INC.ITG2023-10-13
10080196284184MedlineMEDLINE INDUSTRIES, INC.ITG2023-10-12
10080196824779MedlineMEDLINE INDUSTRIES, INC.ITG2023-10-12
10197106447994CARDINAL HEALTHCardinal Health 200, LLCITG2023-10-12
307073877914153M™ Scotchcast™3M COMPANYITG2022-12-08
307073877914223M™ Scotchcast™3M COMPANYITG2022-12-08