CARDINAL HEALTH

Primary DI
50885380019829
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
4854
Catalog number
4854
Device description
SHOECOVER DURA FIT XL 200/PR
Published
2018-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FXPCOVER, SHOE, OPERATING-ROOM

Product Code Classifications

CodeDeviceSpecialtyClass
FXPCover, Shoe, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50885380019829PackageGS14In Commercial Distribution
20885380019828PrimaryGS10
00885380019824Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5088538001982950885380019829
2088538001982820885380019828
00885380019824008853800198248853800198240885380019824

GMDN Terms

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

Regulatory Flags

DUNS number
961027315
Device count
100
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
false

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