FDA.report

DeRoyal

Primary DI
00749756018968
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
9015-02
Catalog number
9015-02
Device description
ELASTIC SHOULDER IMMOBILIZER
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

Related Records

Contact Domains

Product Codes

CodeName
ILISLING, ARM

Product Code Classifications

CodeDeviceSpecialtyClass
ILISling, ArmPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00749756018968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00749756018968007497560189687497560189680749756018968

GMDN Terms

TermDefinition
Shoulder immobilizer, reusableA non-rigid device used to temporarily immobilize or limit abduction of the shoulder joint to support healing of an injury or a surgical wound. It is typically used postoperatively and for post traumatic treatment of injuries in the shoulder and upper arm areas (e.g., distortion/contusion, dislocation/luxation, and postoperative support). It will typically consist of layered fabric, straps, buckles, fasteners and will eliminate most of the work involved with bandaging. This is a reusable device.

Sterilization Methods

Method

Contacts

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 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 DIBrandCompanyProduct codePublished
16974500613613Arm SlingGCMEDICA ENTERPRISE LTD.(WUXI)ILI2025-12-12
16974500613620Arm SlingGCMEDICA ENTERPRISE LTD.(WUXI)ILI2025-12-12
00810113683027Shoulder Brace with Airplane KitManamed, Inc.ILI2025-09-19
00810113683034Shoulder Brace with Airplane Kit LOGOManamed, Inc.ILI2025-09-19
00190446660354PROCAREDJO, LLCILI2025-07-14
50749756397846DeRoyalDEROYAL INDUSTRIES, INC.ILI2025-02-27
00749756397285DeRoyalDEROYAL INDUSTRIES, INC.ILI2025-02-13
00840314811097UNIV ARM SLING W/FOAM STRAP ADULTHausmann Enterprises, LLCILI2025-01-01
10810113576944CoreTechVIVE HEALTH LLCILI2024-06-10
10057475611023BIOS LivingThermor LtdILI2024-05-23
00888912014366DONJOYDJO, LLCILI2024-02-27
07798094540061WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094540078WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094540085WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094540092WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094540108WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094540115WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094540511WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094540528WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094540535WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094540542WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094541105WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094541624WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094547770WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094547787WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094547794WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094547879WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094547886WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094547893WELLBRACEPANTYMED S.A.ILI2024-01-05
07798128672034WELLBRACEPANTYMED S.A.ILI2024-01-05