FDA.reportPublic FDA data

MEDI

Primary DI
00636257009871
Brand
MEDI
Company
MEDI MANUFACTURING, INC.
Model
SL00101
Device description
AC ABDUCTION PILLOW, BLACK, UNIVERSAL
Published
2020-06-01
Public version status
New
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
IOYSUPPORT, ARM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IOYSupport, ArmPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00636257009871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00636257009871006362570098716362570098710636257009871

GMDN Terms#

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

Contacts#

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

Regulatory Flags#

DUNS number
960754430
Device count
1
Premarket exempt
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
06974500613555Elbow SupportGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
06974500613593Shoulder BraceGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
16974500613552Elbow SupportGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
16974500613590Shoulder BraceGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
00810113683041Kangaroo 3960Manamed, Inc.IOY2025-10-17
00636257207710MEDIMEDI MANUFACTURING, INC.IOY2025-09-26
00636257204924MEDIMEDI MANUFACTURING, INC.IOY2025-06-24
00636257204931MEDIMEDI MANUFACTURING, INC.IOY2025-06-24
00636257204948MEDIMEDI MANUFACTURING, INC.IOY2025-06-24
00636257204955MEDIMEDI MANUFACTURING, INC.IOY2025-06-24
04823097723395"TM ""Rehabilitimed"" RP-6 XS Comfort"REABILITIMED TOVIOY2025-05-17
04823097723401"TM ""Rehabilitimed"" RP-6 S Comfort"REABILITIMED TOVIOY2025-05-17
04823097723418"TM ""Rehabilitimed"" RP-6 XS Comfort"REABILITIMED TOVIOY2025-05-17
04823097723425"TM ""Rehabilitimed"" RP-6 S Comfort"REABILITIMED TOVIOY2025-05-17
04823097723432"TM ""Rehabilitimed"" RP-6 M Comfort"REABILITIMED TOVIOY2025-05-17
04823097723449"TM ""Rehabilitimed"" RP-6 L Comfort"REABILITIMED TOVIOY2025-05-17
04823097723456"TM ""Rehabilitimed"" RP-6 XL Comfort"REABILITIMED TOVIOY2025-05-17
04823097723494"TM ""Rehabilitimed"" RP-6P XS Comfort"REABILITIMED TOVIOY2025-05-17
04823097723500"TM ""Rehabilitimed"" RP-6P S Comfort"REABILITIMED TOVIOY2025-05-17
04823097723517"TM ""Rehabilitimed"" RP-6P XS Comfort"REABILITIMED TOVIOY2025-05-17
04823097723524"TM ""Rehabilitimed"" RP-6P S Comfort"REABILITIMED TOVIOY2025-05-17
04823097723531"TM ""Rehabilitimed"" RP-6P M Comfort"REABILITIMED TOVIOY2025-05-17
04823097723548"TM ""Rehabilitimed"" RP-6P L Comfort"REABILITIMED TOVIOY2025-05-17
04823097723555"TM ""Rehabilitimed"" RP-6P XL Comfort"REABILITIMED TOVIOY2025-05-17
04823097723562"TM ""Rehabilitimed"" RP-6K-M UNI Comfort"REABILITIMED TOVIOY2025-05-17
04823097723579"TM ""Rehabilitimed"" RP-6K-M XXL Comfort"REABILITIMED TOVIOY2025-05-17
04823097723586"TM ""Rehabilitimed"" RP-6K-M1 UNIp-2 Comfort"REABILITIMED TOVIOY2025-05-17
04823097723593"TM ""Rehabilitimed"" RP-6K-M1 UNIp-1 Comfort"REABILITIMED TOVIOY2025-05-17
04823097723609"TM ""Rehabilitimed"" RP-6K-M1 UNIp-2 Comfort"REABILITIMED TOVIOY2025-05-17
04823097723616"TM ""Rehabilitimed"" RP-6K-M1 UNIp-1 Comfort"REABILITIMED TOVIOY2025-05-17