FDA.report

NON FRANCHISE

Primary DI
00190446707691
Brand
NON FRANCHISE
Company
DJO, LLC
Model
88-578000370520
Device description
Wrist Hand Thumb Orthosis XS RT
Published
2022-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ILHSPLINT, HAND, AND COMPONENTS
ITQJOINT, KNEE, EXTERNAL BRACE

Product Code Classifications

CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1
ITQJoint, Knee, External BracePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190446707691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446707691001904467076911904467076910190446707691

GMDN Terms

TermDefinition
Wrist orthosisA prefabricated (non-customized) 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

Regulatory Flags

DUNS number
081840873
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
00190446968344DJO SURGICALS-2019632026-03-16
00190446953685DJO SURGICALS-2019592026-02-17
00190446953708DJO SURGICALS-2019582026-02-17
00888912408691DJO SURGICAL800-05-0242023-01-18
00190446940920DJO SURGICALS-2019462025-11-18
00190446660453PROCARE155-81-974272025-07-23
00190446660576PROCARE155-81-971502025-07-23
00190446662686PROCARE155-BH-1942025-07-23
00190446660354PROCARE155-79-843002025-07-14
00190446660583PROCARE155-79-84100C2025-07-14
00190446662785PROCARE155-BH827102025-07-14
00190446662891PROCARE155-81-874802025-07-14
00190446662907PROCARE155-81-874902025-07-14
00190446662914PROCARE155-81-874602025-07-14
00190446662921PROCARE155-81-874702025-07-14
00190446662792PROCARE155-81-873022025-07-11
00190446662808PROCARE155-81-873032025-07-11
00190446662815PROCARE155-81-873052025-07-11
00190446662822PROCARE155-81-873072025-07-11
00190446662839PROCARE155-81-873082025-07-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810220800041Adler Instrument CompanyAdler, Inc.ILH2026-03-17
00817355025806KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-12
00817355025820KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-12
00817355025868KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-12
00817355026247KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-12
00810178883943ViveVIVE HEALTH LLCILH2026-03-06
00817355021976KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025790KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025813KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025837KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025844KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025899KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025912KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025967KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025974KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025981KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026018KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026025KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026032KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026056KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026230KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026292KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026360KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026698KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026711KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026735KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026896KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026902KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355022805KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-05
00817355026667KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-05