FDA.reportPublic FDA data

CASCO

Primary DI
00815073028574
Brand
CASCO
Company
CASCO MANUFACTURING SOLUTIONS, INC.
Model
P10015
Catalog number
P10015
Device description
DISPOSABLE BOOTIES, KNEE HIGH
Published
2020-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FXPCover, Shoe, Operating-Room

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXPCover, Shoe, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815073028574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815073028574008150730285748150730285740815073028574

GMDN Terms#

Term, Definition table
TermDefinition
Shoe cover, non-conductive, non-sterileA non-sterile device made of a non-conductive material intended to be used as a physical barrier on a shoe to prevent cross-contamination between the shoe and the environment. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
513-681-0003MJOHNSON@CASCOMFG.COM

Regulatory Flags#

DUNS number
004253936
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815073029458CMATTH12642H126422021-07-26
00810125100710CMATTH11895H118952023-01-09
00815073029977CMATTH12698H126982022-06-06
00815073029991CMATTH12694H126942022-05-17
00815073029946CASCO21771217712022-01-14
00815073029953CMATTH12136-PH12136-P2022-01-14
00815073029939CMATTH12687H126872021-12-21
00815073029915CMATTH12686H126862021-11-30
00815073029908CMATTH10407H104072021-10-04
00815073029847CASCOH12677H126772021-08-24
00815073029854CASCOH12678H126782021-08-24
00815073029861CASCOH12679H126792021-08-24
00815073029878CASCOH12680H126802021-08-24
00815073029809CASCOH12673H126732021-08-20
00815073029816CASCOH12674H126742021-08-20
00815073029823CASCOH12675H126752021-08-20
00815073029830CASCOH12676H126762021-08-20
00815073029793CASCOH12672H126722021-08-19
00815073029786CASCOH12671H126712021-08-17
00815073029762CASCOH12669H126692021-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30080196291513MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-09-22
30080196300901MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-09-22
30080196300918MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-09-22
30080196303599MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-09-22
30080196720174MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-09-22
30080196721751MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-09-22
30884389141810MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-09-22
00840456217566JMUJMU DENTAL, INCFXP2026-07-07
00860012300792JMUJMU DENTAL, INCFXP2026-07-07
00199536901209BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901216BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901223BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901230BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901247BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901254BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901261BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901278BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
20197344164049MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-03-30
20197344133120MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-03-06
20197344151575MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-03-06
10197344103973MEDLINEMEDLINE INDUSTRIES, INC.FXP2025-04-05
10810141933214VIVIT SupplyVivit Supply LLCFXP2024-11-29
10810141933221VIVIT SupplyVivit Supply LLCFXP2024-11-29
10850053289504SURGYCOSurgyco LLCFXP2024-08-09
20197344036117MedlineMEDLINE INDUSTRIES, INC.FXP2024-02-16
20197344074454MedlineMEDLINE INDUSTRIES, INC.FXP2024-02-16
20197344036049MedlineMEDLINE INDUSTRIES, INC.FXP2024-01-01
20197344036056MedlineMEDLINE INDUSTRIES, INC.FXP2024-01-01
20197344029607MedlineMEDLINE INDUSTRIES, INC.FXP2023-12-22
20197344029614MedlineMEDLINE INDUSTRIES, INC.FXP2023-12-19