FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756098724
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
7119-00
Catalog number
7119-00
Device description
CANVAS WEIGHT BAG
Published
2021-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00749756098724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00749756098724007497560987247497560987240749756098724

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
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756402316DeRoyalNP-6006ULNP-6006UL2026-10-16
00749756402323DeRoyalNP-6007ULNP-6007UL2026-10-16
00749756402330DeRoyalNP-6008ULNP-6008UL2026-10-16
00749756402347DeRoyalNP-0080ULNP-0080UL2026-10-16
00749756402354DeRoyalNP-6014ULNP-6014UL2026-10-16
00749756402361DeRoyalNP-6015ULNP-6015UL2026-10-16
00749756402378DeRoyalNP-6016ULNP-6016UL2026-10-16
00749756402989DeRoyalNP-0250UNP-0250U2026-09-30
00749756402996DeRoyalNP-0450UNP-0450U2026-09-30
00749756403009DeRoyalNP-0450UNNP-0450UN2026-09-30
00749756403016DeRoyalNP-0250UNNP-0250UN2026-09-30
00749756403023DeRoyalNP-0250U-01NP-0250U-012026-09-30
00749756403375DeRoyal31-120P31-120P2026-09-30
00749756369640DeRoyalNP-7000NP-70002026-09-23
00749756389181DeRoyal81-1020SU81-1020SU2026-09-21
00749756389204DeRoyal81-1020REF81-1020REF2026-09-21
00749756399258DeRoyal46-326XBNS46-326XBNS2026-09-21
00749756400442DeRoyal77-40111877-4011182026-09-21
00749756985475DeRoyalNP-790NP-7902026-09-21
00749756985963DeRoyalNP-7300-01NP-7300-012026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00636257220733MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220740MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220757MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220764MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220771MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220788MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220795MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220801MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220887MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220894MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220900MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220917MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220924MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220931MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220948MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220955MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220962MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220979MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220986MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220993MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257221006MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257221068MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257221075MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257221082MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00840536824288PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824295PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824301PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824318PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824325PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824332PediHipORTHOPEDIATRICS CORP.IQI2026-10-07