FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756018425
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
8824-04
Catalog number
8824-04
Device description
WRIST AND FOREARM
Published
2021-07-29
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILHSPLINT, HAND, AND COMPONENTS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00749756018425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00749756018425007497560184257497560184250749756018425

GMDN Terms#

Term, Definition table
TermDefinition
Hand/finger splint, single-useA 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 single-patient device that may be reapplied over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50749756033140DeRoyal10-513010-51302023-01-31
50749756392490DeRoyalNP-6006UNP-6006U2026-01-22
50749756397808DeRoyalNP-0080LMDNP-0080LMD2026-01-22
00749756401258DeRoyalSTM2000STM20002026-01-22
50749756401352DeRoyalM60-AP500M60-AP5002026-01-22
50749756401376DeRoyalM60-AP600M60-AP6002026-01-22
50749756401383DeRoyalM60-AP601M60-AP6012026-01-22
50749756401390DeRoyalM60-AP602M60-AP6022026-01-22
50749756401482DeRoyal46-LT19S-01B46-LT19S-01B2026-01-22
50749756401437DeRoyalM70-200PM70-200P2026-01-01
50749756401444DeRoyalM70-200CM70-200C2026-01-01
50749756401451DeRoyalM70-200CNWM70-200CNW2026-01-01
50749756401468DeRoyalM70-200PNWM70-200PNW2026-01-01
50749756394418DeRoyal71-080571-08052025-08-13
50749756396641DeRoyalPH81-010400PH81-0104002025-08-13
50749756397853DeRoyalPH81-020409PH81-0204092025-08-13
50749756397860DeRoyalPH81-020412PH81-0204122025-08-13
00749756399333DeRoyal1-524A-01-CHO1-524A-01-CHO2025-07-30
00749756399340DeRoyal1-524A-02-CHO1-524A-02-CHO2025-07-30
00749756399357DeRoyal1-524A-03-CHO1-524A-03-CHO2025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800041Adler Instrument CompanyAdler, Inc.ILH2026-03-17
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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
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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
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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