FDA.reportPublic FDA data

MediChoice

Primary DI
50885632105331
Brand
MediChoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
77729
Device description
Cover Shoe Fluid-Resistant Durable Elastic Band Upper Extra-Large Spun Bond Polypropylene Blue Not Made With Natural Rubber Latex MediChoice
Published
2020-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
50885632105331PackageGS13In Commercial Distribution
30885632105337PrimaryGS10
10885632105333Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088563210533150885632105331
3088563210533730885632105337
1088563210533310885632105333

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

Regulatory Flags#

DUNS number
007941230
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885632434266Halyard563482026-05-22
10885632434303Halyard563522026-05-22
10885632468490Halyard614862026-05-22
10885632468506Halyard614872026-05-22
10885632468513Halyard614882026-05-22
10885632468520Halyard614892026-05-22
10885632509032Halyard620732026-05-22
10885632509049Halyard620742026-05-22
10885632509056Halyard620752026-05-22
10885632509063Halyard620762026-05-22
10885632510199Halyard620772026-05-22
10885632521751SurgiTrackSM450130D17D2026-05-22
10885632521607SurgiTrackSM4500452F842026-05-19
10885632521638SurgiTrackSM45007841332026-05-19
10885632521522SurgiTrackSM4500410A672026-05-18
10885632521577SurgiTrackSM450041BC2C2026-05-18
10885632521584SurgiTrackSM45004117402026-05-18
10885632521591SurgiTrackSM45004113802026-05-18
10885632521317SurgiTrackSM450178CA972026-05-13
10885632434228Halyard563442026-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
30080196745795MedlineMEDLINE INDUSTRIES, INC.FXP2023-10-12
10810141930435VIVIT SupplyVivit Supply LLCFXP2023-09-15
10810141930442VIVIT SupplyVivit Supply LLCFXP2023-09-15
10810141930626Vivit SupplyVivit Supply LLCFXP2023-09-15
10810141930633Vivit SupplyVivit Supply LLCFXP2023-09-15
10810141930923VIVIT SupplyVivit Supply LLCFXP2023-09-15
10810141930930VIVIT SupplyVivit Supply LLCFXP2023-09-15
10097604459546Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXP2023-08-28
10097604469750Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXP2023-08-28
10849233004877Busse Hospital DisosablesROBERT BUSSE & CO., INC.FXP2023-06-16
10849233005003Busse Hospital DisposablesROBERT BUSSE & CO., INC.FXP2023-06-16
10097604470022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXP2023-04-10
10097604472248Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXP2023-04-10
10097604474754Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXP2023-04-10
10850044799586SURGYCOSurgyco LLCFXP2023-02-16
20192253063322CARDINAL HEALTHCardinal Health 200, LLCFXP2023-01-13
10810087350175CoulmedCoulmed Products Group LLCFXP2023-01-06