FDA.reportPublic FDA data

EXOS

Primary DI
00190446141310
Brand
EXOS
Company
DJO, LLC
Model
311-32-2293
Device description
SHRT ARM FRACTURE BRACE, OPEN THUMB, SPIDER, RT, 1XS/PEDS
Published
2023-09-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IQIORTHOSIS, LIMB BRACE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446141310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446141310001904461413101904461413100190446141310

GMDN Terms#

Term, Definition table
TermDefinition
Hand/finger splint, reusableA prefabricated (non-customized) wearable rigid or semi-rigid device intended to immobilize an injured/diseased hand and/or finger to support, align or prevent injury during the healing process. It is applied externally to the hand/finger/wrist and typically held in place with self-retaining fasteners (e.g., Velcro bands) or bandage wraps. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081840873
Device count
1
Premarket exempt
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446979128AIRCAST31M-9002026-08-03
00190446898610CMFMFUSE012026-07-31
00190446660590PROCARE155-79-871132026-07-31
00190446660606PROCARE155-79-871142026-07-31
00190446660613PROCARE155-79-871172026-07-31
00190446660620PROCARE155-79-871182026-07-31
00190446660637PROCARE155-79-870502026-07-31
00190446660644PROCARE155-79-870602026-07-31
00190446922490CMFMANAGEL012026-07-31
00190446780601CHATTANOOGA81-50102023-04-25
00190446780618CHATTANOOGA81-50112023-04-25
00190446750598CHATTANOOGA47382022-09-02
00190446750604CHATTANOOGA47822022-09-02
00190446757214CHATTANOOGA4782-12022-09-02
00190446757221CHATTANOOGA4738-12022-09-02
00888912036627PROCARE79-892002022-08-22
00888912292856CHATTANOOGA2761-102016-09-15
00888912292863CHATTANOOGA2761-22016-09-15
00888912294249CHATTANOOGA2789-102016-09-15
00888912294256CHATTANOOGA2789-22016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840536801074PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536801081PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536806390PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823571PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823588PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823595PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823601PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823618PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823625PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823632PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823649PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823656PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823663PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823670PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823687PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823694PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823700PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824165PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824172PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824189PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824196PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824202PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824219PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824226PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824233PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824240PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824257PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824264PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824271PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824769PediHipORTHOPEDIATRICS CORP.IQI2026-10-01