FDA.reportPublic FDA data

McKesson

Primary DI
00612479174351
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16-3558
Device description
Shoe Covers Fluid Resistant, Non skid, Blue, 2X-Large
Published
2019-10-22
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

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
00612479174351PackageGS12In Commercial Distribution
00612479174344PrimaryGS10
00612479236585Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479174351006124791743516124791743510612479174351
00612479174344006124791743446124791743440612479174344
00612479236585006124792365856124792365850612479236585

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/examination garment kitA collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
Device count
50
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
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

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