FDA.report

MEDI

Primary DI
00636257014615
Brand
MEDI
Company
MEDI MANUFACTURING, INC.
Model
KAK2L5W3
Device description
!30-40 SHRINKER AK 12" LONG BLACK SZ 3
Published
2020-10-14
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

Related Records

Product Codes

CodeName
IPMCOVER, LIMB

Product Code Classifications

CodeDeviceSpecialtyClass
IPMCover, LimbPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00636257014615PrimaryGS10

GMDN Terms

TermDefinition
Limb-worn device coverA device made of fabric or harder materials designed to cover an external prosthetic or orthotic device worn on a limb (e.g., cast, foot orthosis), or an external fixation system for a limb, primarily to function as a hygienic barrier to protect the device and patient from contamination. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-6334info@mediusa.com

Regulatory Flags

DUNS number
960754430
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
false
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 DIBrandModelCatalogPublished
00636257211281MEDIKCOR2CM12026-03-17
00636257211298MEDIKCOR2CM22026-03-17
00636257211304MEDIKCOR2CM32026-03-17
00636257211311MEDIKCOR2CM42026-03-17
00636257211328MEDIKCOR2LT12026-03-17
00636257211335MEDIKCOR2LT22026-03-17
00636257211342MEDIKCOR2LT32026-03-17
00636257211359MEDIKCOR2LT42026-03-17
00636257211366MEDIKCOR2MC12026-03-17
00636257211373MEDIKCOR2MC22026-03-17
00636257211380MEDIKCOR2MC32026-03-17
00636257211397MEDIKCOR2MC42026-03-17
00636257211403MEDIKBST2DR12026-03-17
00636257211410MEDIKBST2DR22026-03-17
00636257211427MEDIKBST2DR32026-03-17
00636257211434MEDIKBST2DR42026-03-17
00636257211441MEDIKBST2FG12026-03-17
00636257211458MEDIKBST2FG22026-03-17
00636257211465MEDIKBST2FG32026-03-17
00636257211472MEDIKBST2FG42026-03-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20809160489885Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.IPM2025-08-01
20809160489465Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.IPM2025-07-31
08717127934409Arion Easy-Slide Arion Holding B.V.IPM2025-02-03
08717127934416Arion MagnideArion Holding B.V.IPM2025-02-03
08717127934423Arion Sim-Slide Arion Holding B.V.IPM2025-02-03
08717127934430Arion Easy-OffArion Holding B.V.IPM2025-02-03
08717127934447Arion Easy-Slide ArmArion Holding B.V.IPM2025-02-03
08717127934454Arion Proth-ProArion Holding B.V.IPM2025-02-03
08717127930111Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930401Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930432Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930463Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930494Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930555Arion MagnideArion Holding B.V.IPM2025-01-13
08717127930586Arion MagnideArion Holding B.V.IPM2025-01-13
08717127930616Arion Magnide 2in1Arion Holding B.V.IPM2025-01-13
08717127930647Arion Magnide 2in1Arion Holding B.V.IPM2025-01-13
08717127930678Arion Magnide 2in1Arion Holding B.V.IPM2025-01-13
08717127930708Arion Sim-Slide Arion Holding B.V.IPM2025-01-13
08717127930739Arion Sim-Slide Arion Holding B.V.IPM2025-01-13
08717127930760Arion Sim-Slide Arion Holding B.V.IPM2025-01-13
08717127930791Arion Sim-Slide Arion Holding B.V.IPM2025-01-13
08717127930821Arion Easy-OffArion Holding B.V.IPM2025-01-13
08717127930852Arion Easy-OffArion Holding B.V.IPM2025-01-13
08717127930883Arion Easy-OffArion Holding B.V.IPM2025-01-13
08717127930913Arion Easy-Slide ArmArion Holding B.V.IPM2025-01-13
08717127930944Arion Easy-Slide ArmArion Holding B.V.IPM2025-01-13
08717127930975Arion SlideXArion Holding B.V.IPM2025-01-13
08717127931002Arion SlideXArion Holding B.V.IPM2025-01-13
08717127931040Arion SlideXArion Holding B.V.IPM2025-01-13