FDA.reportPublic FDA data

Dukal

Primary DI
20665973003379
Brand
Dukal
Company
Dukal LLC
Model
350
Catalog number
350
Device description
Non-Skid Shoe Cover
Published
2022-12-06
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

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
20665973003379PackageGS13In Commercial Distribution
10665973003372PrimaryGS10
00665973003375Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2066597300337920665973003379
1066597300337210665973003372
00665973003375006659730033756659730033750665973003375

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(631)656-3800kmckigney@dukal.com

Regulatory Flags#

DUNS number
791014871
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
20665973032638Dukal550055002026-01-12
20665973032645Dukal550155012026-01-12
30665973032659Dukal550255022026-01-12
30665973032666Dukal550355032026-01-12
20665973033024Dukal553055302026-02-26
20665973020918Dukal11130111302026-01-30
20665973020932Dukal11127111272026-01-30
30665973032611Dukal986098602025-10-31
30665973032628Dukal986198612025-10-31
30665973032598DukalK-10040K-100402025-09-18
30665973032451UnipackUPP-1015UPP-10152025-06-01
30665973032475UnipackUPP-223UPP-2232025-06-01
30665973032482UnipackUPP-225UPP-2252025-06-01
30665973032499UnipackUPP-29UPP-292025-06-01
30665973032505UnipackUPP-3212UPP-32122025-06-01
30665973032512UnipackUPP-3565UPP-35652025-06-01
30665973032529UnipackUPP-4212UPP-42122025-06-01
30665973032536UnipackUPP-5211UPP-52112025-06-01
30665973032543UnipackUPP-5275UPP-52752025-06-01
30665973032550UnipackUPP-7513UPP-75132025-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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