FDA.reportPublic FDA data

RTMED

Primary DI
06971642800706
Brand
RTMED
Company
Shandong Haidike Medical Products Co., Ltd.
Model
Nonwoven fabric type, PVC type 50 / bag, 100 / bag
Published
2022-12-07
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
06971642800706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971642800706069716428007066971642800706

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

Regulatory Flags#

DUNS number
550402542
Device count
1
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971642801390RTMED2/0 75cm Reverse Cutting 3/8 26mm2024-02-22
06971642801413RTMED2/0 75cm Cutting 3/8 30mm2024-02-22
06971642804285RTMED2 Without Needle 150cm2024-02-22
06971642804292RTMED6/0 Without Needle 150cm2024-02-22
06971642804308RTMED5/0 75cm Cutting 3/8 16mm2024-02-22
06971642804315RTMED5/0 75cm Round Bodied 1/2 13mm2024-02-22
06971642804322RTMED5/0 Without Needle 150cm2024-02-22
06971642804346RTMED4/0 75cm Reverse Cutting 3/8 19mm2024-02-22
06971642804353RTMED4/0 75cm Round Bodied 1/2 16mm2024-02-22
06971642804360RTMED4/0 Without Needle 150cm2024-02-22
06971642804377RTMED3/0 75cm Reverse Cutting 3/8 19mm2024-02-22
06971642804384RTMED3/0 75cm Cutting 3/8 24mm2024-02-22
06971642804391RTMED3/0 75cm Reverse Cutting 3/8 26mm2024-02-22
06971642804407RTMED3/0 75cm Cutting 3/8 30mm2024-02-22
06971642804414RTMED3/0 75cm Round Bodied 1/2 30mm2024-02-22
06971642804421RTMED3/0 Without Needle 150cm2024-02-22
06971642801420RTMED2/0 75cm Round Bodied 1/2 24mm2024-02-23
06971642801437RTMED2/0 75cm Round Bodied 1/2 35mm2024-02-23
06971642801444RTMED2/0 Without Needle 150cm2024-02-23
06971642801451RTMED0 75cm Reverse Cutting 3/8 37mm2024-02-23

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