FDA.reportPublic FDA data

MEDI

Primary DI
04026398796086
Brand
MEDI
Company
MEDI MANUFACTURING, INC.
Model
64281
Device description
***DISC*MANUMED ACTIVE WRIST LEFT SAND X
Published
2019-02-11
Public version status
Update
Distribution status
Not 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
ISZUNIT, WRIST, EXTERNAL LIMB COMPONENT, MECHANICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISZUnit, Wrist, External Limb Component, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026398796086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026398796086040263987960864026398796086

GMDN Terms#

Term, Definition table
TermDefinition
Wrist orthosisAn externally applied orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the wrist. 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
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
04262429650884Explorer Hold Lock Modulemacu4 GmbHISZ2026-03-23
04262429650006Explorer Bike Module STD without spacermacu4 GmbHISZ2025-11-23
04262429650013Explorer Bike Module STD with spacermacu4 GmbHISZ2025-11-23
04262429650020Explorer Ball Module STD without spacermacu4 GmbHISZ2025-11-23
04262429650037Explorer Ball Module STD with spacermacu4 GmbHISZ2025-11-23
04262429650044Explorer Ball Module SML without spacermacu4 GmbHISZ2025-11-23
04262429650051Explorer Ball Module SML with spacermacu4 GmbHISZ2025-11-23
04262429650068Explorer Swim Module STD without spacermacu4 GmbHISZ2025-11-23
04262429650075Explorer Swim Module SML without spacermacu4 GmbHISZ2025-11-23
04262429650082Explorer Twin Module STD without spacermacu4 GmbHISZ2025-11-23
04262429650099Explorer Twin Module STD with spacermacu4 GmbHISZ2025-11-23
04262429650105Explorer Twin Module LRG without spacermacu4 GmbHISZ2025-11-23
04262429650112Explorer Twin Module LRG with spacermacu4 GmbHISZ2025-11-23
04262429650136Explorer Ring STDmacu4 GmbHISZ2025-11-23
04262429650143Explorer Pinch Module STD without spacermacu4 GmbHISZ2025-11-23
04262429650150Explorer Pinch Module spacermacu4 GmbHISZ2025-11-23
04262429650297Explorer Ring EXPmacu4 GmbHISZ2025-11-23
04262429650303Explorer Hold Module STD without spacermacu4 GmbHISZ2025-11-23
04262429650310Explorer Hold Module spacermacu4 GmbHISZ2025-11-23
09421037390383Low Profile Lamination Kit, CX, 50mm TASKA PROSTHETICS LIMITEDISZ2025-07-29
09421037390451MC Seal Ring Kit, Medium/Large, SandTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421037390505TASKA Seal Ring Kit, 50mm, SandTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421906785425MC Seal Ring Kit, Medium/Large, BlackTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421906785432TASKA Seal Ring Kit, 50mm, BlackTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421906785944MC Seal Ring Kit, Small, BlackTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421906785951MC Seal Ring Kit, Small, Sand TASKA PROSTHETICS LIMITEDISZ2025-07-29
09421906785982TASKA Seal Ring Kit, 45mm, BlackTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421906785999TASKA Seal Ring Kit, 45mm, SandTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421037390390TASKA Lamination Collar Kit (6-band), 50mm, BlackTASKA PROSTHETICS LIMITEDISZ2025-07-28
09421037390406TASKA Lamination Collar Kit (6-band), 50mm, Sand TASKA PROSTHETICS LIMITEDISZ2025-07-28