FDA.report

AMD-RITMED

Primary DI
20686864052276
Brand
AMD-RITMED
Company
AMD Medicom Inc
Model
A8007-HT-XL
Catalog number
A8007-HT-XL
Device description
AMD-RITMED HIGH TOP BOOT COVER X-Large
Published
2019-01-16
Public version status
Update
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

Contact Domains

Product Codes

CodeName
FXPCOVER, SHOE, OPERATING-ROOM

Product Code Classifications

CodeDeviceSpecialtyClass
FXPCover, Shoe, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20686864052276PackageGS13In Commercial Distribution
10686864052279PrimaryGS10
00686864052272Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2068686405227620686864052276
1068686405227910686864052279
00686864052272006868640522726868640522720686864052272

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Cool dry place

Sterilization Methods

Method

Contacts

PhoneEmail
+1(514)636-6262amdudi@medicom.ca

Regulatory Flags

DUNS number
256880576
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 DIBrandModelCatalogPublished
20686864061933MEDICOM ASSUREMASK VALIANT205915-B205915-B2026-03-17
20686864061940MEDICOM ASSUREMASK VALIANT205915-C205915-C2026-03-17
20686864060943MEDICOM DENTICARE 10067100672026-02-25
20686864060950MEDICOM DENTICARE 10068100682026-02-25
D8304405062PROFESSIONAL'S CHOICE4405064405062026-02-10
D8305514332MEDICOM5514335514332026-02-10
20686864061643MEDICOM2244152244152025-11-20
20686864061650MEDICOM224415.001224415.0012025-11-20
20686864061735MEDICOM224415.002224415.0022025-11-20
20686864061469Medicom SafeBasics2101-CHUS2101-CHUS2025-05-13
20686864061476AMD-RitmedA2100-CHUSA2100-CHUS2025-05-13
20686864061483AMD-RitmedA2101-CHUSA2101-CHUS2025-05-13
20686864061490AMD-RitmedA2103-CHUSA2103-CHUS2025-05-13
20686864051538AMD-RITMEDA60044A600442019-01-13
20686864061452Medicom SafeBasics2100-CHUS2100-CHUS2025-05-06
20686864061377Medicom AssureTouch9940-A9940-A2025-04-24
20686864061384Medicom AssureTouch9940-B9940-B2025-04-24
00686864061397Medicom AssureTouch9940-C9940-C2025-04-24
20686864061407Medicom AssureTouch9940-D9940-D2025-04-24
00686864061410Medicom AssureTouch9940-E9940-E2025-04-24

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