FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756016988
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
8105-02
Catalog number
8105-02
Device description
BUCKS TRACTION
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
HSPSPLINT, TRACTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSPSplint, TractionOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00749756016988PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00749756016988007497560169887497560169880749756016988

GMDN Terms#

Term, Definition table
TermDefinition
Traction system beltA harness designed to provide traction to the lower spine, including the lumbar and pelvic areas, with force from an external traction system. It is typically a padded piece of material (e.g., cotton, vinyl) that is placed around the waist, and has one or more straps with rings at the end that permit its attachment to the traction system's cable. It may include additional rings for attachment to a spreader bar. The harness is used mainly for relief of low back pain and to maintain normal alignment of the vertebrae.

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
06974567745909RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2024-05-13
16974567745906RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2024-05-13
06974567746937RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-06-28
16974567746934RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-06-28
05060483570051Prometheus Traction Splint SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDHSP2023-05-01
16952534421022SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421039SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421046SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421053SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421060SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421114SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421121SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421138SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421145SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421152SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421169SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
06974567747811RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-03-21
06974567747828RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-03-21
06974567748092RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-03-03
16974567748099RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-03-03
26974567748133RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-02-27
26974567748140RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-02-27
26974567748157RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-02-27
26974567748164RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-02-27
06974567748139RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-02-20
06974567748146RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-02-20
06974567748153RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-02-20
06974567748160RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-02-20
10609271080604BUCKS TRACTION w/LINERDARCO INTERNATIONAL, INC.HSP2023-02-08
06971642800034RTMEDShandong Haidike Medical Products Co., Ltd.HSP2022-12-07