FDA.reportPublic FDA data

MEDI

Primary DI
00636257116852
Brand
MEDI
Company
MEDI MANUFACTURING, INC.
Model
63104
Device description
M4S OA COMPACT VARUS RIGHT L
Published
2018-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IQIORTHOSIS, LIMB BRACE
ITQJOINT, KNEE, EXTERNAL BRACE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1
ITQJoint, Knee, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00636257116852PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00636257116852006362571168526362571168520636257116852

GMDN Terms#

Term, Definition table
TermDefinition
Knee orthosisAn externally applied orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the knee. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-6334info@mediusa.com

Regulatory Flags#

DUNS number
960754430
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00636257213469MEDIDB1812026-05-07
00636257213551MEDISP171N12026-05-07
00636257213568MEDISP171N22026-05-07
00636257213575MEDISP171N32026-05-07
00636257213582MEDISP171N42026-05-07
00636257213599MEDISP171N52026-05-07
00636257213605MEDISP172N12026-05-07
00636257213612MEDISP172N22026-05-07
00636257213629MEDISP172N32026-05-07
00636257213636MEDISP172N42026-05-07
00636257213643MEDISP172N52026-05-07
00636257213650MEDISM171N12026-05-07
00636257213667MEDISM171N22026-05-07
00636257213674MEDISM171N32026-05-07
00636257213681MEDISM171N42026-05-07
00636257213698MEDISM171N52026-05-07
00636257213704MEDISM172N12026-05-07
00636257213711MEDISM172N22026-05-07
00636257213728MEDISM172N32026-05-07
00636257213735MEDISM172N42026-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841156111298ACCUMEDTELEFLEX INCORPORATEDIQI2025-03-11
10841156111304ACCUMEDTELEFLEX INCORPORATEDIQI2025-03-11
07798128672539WELLBRACEPANTYMED S.A.IQI2024-01-09
07798128676148PROFITPANTYMED S.A.IQI2024-01-09
07798094546148WELLBRACEPANTYMED S.A.IQI2024-01-08
07798094546155WELLBRACEPANTYMED S.A.IQI2024-01-08
07798094547954WELLBRACEPANTYMED S.A.IQI2024-01-08
07798094547961WELLBRACEPANTYMED S.A.IQI2024-01-08
07798094549446PROFITPANTYMED S.A.IQI2024-01-08
07798128672188WELLBRACEPANTYMED S.A.IQI2024-01-08
07798128672195WELLBRACEPANTYMED S.A.IQI2024-01-08
07798128672546WELLBRACEPANTYMED S.A.IQI2024-01-08
07798128672553WELLBRACEPANTYMED S.A.IQI2024-01-08
07798128672577WELLBRACEPANTYMED S.A.IQI2024-01-08
07798128672584WELLBRACEPANTYMED S.A.IQI2024-01-08
07798128672591WELLBRACEPANTYMED S.A.IQI2024-01-08
07798128672607WELLBRACEPANTYMED S.A.IQI2024-01-08
07798128675394PROFITPANTYMED S.A.IQI2024-01-08
07798128675400PROFITPANTYMED S.A.IQI2024-01-08
07798128675417PROFITPANTYMED S.A.IQI2024-01-08
07798128676100PROFITPANTYMED S.A.IQI2024-01-08
07798128676117PROFITPANTYMED S.A.IQI2024-01-08
07798128676124PROFITPANTYMED S.A.IQI2024-01-08
07798128676155PROFITPANTYMED S.A.IQI2024-01-08
07798128676162PROFITPANTYMED S.A.IQI2024-01-08
00057475210434BIOS LivingThermor LtdITQ2023-03-31
00609271950030MECRON Hip-Compression U: 95-115 cmDarco (Europe) GmbHIQI2023-02-14
00609271950047MECRON Hip-Compression U: 95-115 cmDarco (Europe) GmbHIQI2023-02-14
00609271950054MECRON Hip-Compression U: 105-125 cmDarco (Europe) GmbHIQI2023-02-14
00609271950061MECRON Hip-Compression U: 105-125 cmDarco (Europe) GmbHIQI2023-02-14