FDA.report

DeRoyal

Primary DI
50749756325375
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
32-1595
Catalog number
32-1595
Device description
Custom Shoe Covers
Published
2021-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FXPCOVER, SHOE, OPERATING-ROOM

Product Code Classifications

CodeDeviceSpecialtyClass
FXPCover, Shoe, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50749756325375PackageGS150In Commercial Distribution
00749756325370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975632537550749756325375
00749756325370007497563253707497563253700749756325370

GMDN Terms

TermDefinition
Shoe coverA loose fabric covering intended to be placed over a shoe to create a physical barrier to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the shoe and the environment, or a patient and staff. It is typically used in areas such as examination rooms or operating theatres and may be conductive, to reduce the risk of static electricity, or non-conductive. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags

DUNS number
096372255
Device count
1
DM exempt
true
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 DIBrandModelCatalogPublished
50749756033140DeRoyal10-513010-51302023-01-31
50749756392490DeRoyalNP-6006UNP-6006U2026-01-22
50749756397808DeRoyalNP-0080LMDNP-0080LMD2026-01-22
00749756401258DeRoyalSTM2000STM20002026-01-22
50749756401352DeRoyalM60-AP500M60-AP5002026-01-22
50749756401376DeRoyalM60-AP600M60-AP6002026-01-22
50749756401383DeRoyalM60-AP601M60-AP6012026-01-22
50749756401390DeRoyalM60-AP602M60-AP6022026-01-22
50749756401482DeRoyal46-LT19S-01B46-LT19S-01B2026-01-22
50749756401437DeRoyalM70-200PM70-200P2026-01-01
50749756401444DeRoyalM70-200CM70-200C2026-01-01
50749756401451DeRoyalM70-200CNWM70-200CNW2026-01-01
50749756401468DeRoyalM70-200PNWM70-200PNW2026-01-01
50749756394418DeRoyal71-080571-08052025-08-13
50749756396641DeRoyalPH81-010400PH81-0104002025-08-13
50749756397853DeRoyalPH81-020409PH81-0204092025-08-13
50749756397860DeRoyalPH81-020412PH81-0204122025-08-13
00749756399333DeRoyal1-524A-01-CHO1-524A-01-CHO2025-07-30
00749756399340DeRoyal1-524A-02-CHO1-524A-02-CHO2025-07-30
00749756399357DeRoyal1-524A-03-CHO1-524A-03-CHO2025-07-30

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10810132044332HCSConcordance Healthcare Solutions LLCFXP2026-03-09
10810132044349HCSConcordance Healthcare Solutions LLCFXP2026-03-09
10197344133123MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-03-06
10197344151578MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-03-06
00612479277038McKessonMCKESSON MEDICAL-SURGICAL INC.FXP2025-07-28
00612479277052McKessonMCKESSON MEDICAL-SURGICAL INC.FXP2025-07-28
00612479277076McKessonMCKESSON MEDICAL-SURGICAL INC.FXP2025-07-28
00612479277090McKessonMCKESSON MEDICAL-SURGICAL INC.FXP2025-07-28
20197344103970MEDLINEMEDLINE INDUSTRIES, INC.FXP2025-04-05
00612479250543McKessonMCKESSON MEDICAL-SURGICAL INC.FXP2025-03-18
00612479250574McKessonMCKESSON MEDICAL-SURGICAL INC.FXP2025-03-18
00690521019201Batrik ShoozCovers™ Batrik Medical Manufacturing IncFXP2025-02-14
00690521019218Batrik ShoozCovers™ Batrik Medical Manufacturing IncFXP2025-02-14
00690521020948Batrik ShoozCovers™ Batrik Medical Manufacturing IncFXP2025-02-14
00690521020955Batrik ShoozCovers™ Batrik Medical Manufacturing IncFXP2025-02-14
00690521020986Batrik ShoozCovers™ Batrik Medical Manufacturing IncFXP2025-02-14
00690521021365Batrik ShoozCovers™ Batrik Medical Manufacturing IncFXP2025-02-14
00690521021396Batrik ShoozCovers™ Batrik Medical Manufacturing IncFXP2025-02-14
00690521021419Batrik ShoozCovers™ Batrik Medical Manufacturing IncFXP2025-02-14
00690521021426Batrik ShoozCovers™ Batrik Medical Manufacturing IncFXP2025-02-14
00690521022683Batrik ShoozCovers™ Batrik Medical Manufacturing IncFXP2025-02-14
00690521022690Batrik ShoozCovers™ Batrik Medical Manufacturing IncFXP2025-02-14
00690521022881Batrik ShoozCovers™ Batrik Medical Manufacturing IncFXP2025-02-14
00690521022904Batrik ShoozCovers™ Batrik Medical Manufacturing IncFXP2025-02-14
00690521022928Batrik ShoozCovers™ Batrik Medical Manufacturing IncFXP2025-02-14
00690521025172Batrik ShoozCovers™ Batrik Medical Manufacturing IncFXP2025-02-14
10326053120777Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.FXP2025-02-06
10326053120784Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.FXP2025-01-28
20810141933211VIVIT SupplyVivit Supply LLCFXP2024-11-29
20810141933228VIVIT SupplyVivit Supply LLCFXP2024-11-29