FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756007009
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
4005-04
Catalog number
4005-04
Device description
Ankle Support
Published
2021-07-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQLSTOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQLStocking, Medical Support (For General Medical Purposes)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00749756007009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00749756007009007497560070097497560070090749756007009

GMDN Terms#

Term, Definition table
TermDefinition
Ankle/foot orthosisAn externally-applied appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot; it may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds. It is made of metal, synthetic, and/or textile materials and may include customizable plantar inserts. This is a single-patient use device that can be reapplied to the patient during the treatment period (reusable) 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
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
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
00749756985994DeRoyalNP-7300NP-73002026-09-21
00749756986250DeRoyalNP-7300NNP-7300N2026-09-21
00749756394666DeRoyal47-820KG47-820KG2026-09-18
00749756397193DeRoyal47-813KG-0147-813KG-012026-09-18
00749756397339DeRoyal15410002154100022026-09-18
00749756397346DeRoyal15410003154100032026-09-18
00749756400800DeRoyal32-219532-21952026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00674854000013SOFT SOCK ®Thuasne LLCFQL2018-12-31
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00674854000037SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000044SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000068SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000075SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000082SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000099SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000105SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000112SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000129SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000136SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000143SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000150SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000167SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000174SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000181SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000198SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000204SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000211SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000228SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000235SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000242SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000259SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000266SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000273SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000280SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000297SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000303SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000310SOFT SOCK ®Thuasne LLCFQL2018-12-31