FDA.reportPublic FDA data

ROYAL FLUSH

Primary DI
G296OXHRF3AB120
Brand
ROYAL FLUSH
Company
Royal Knit, Inc.
Model
OXHRF3-A/B-12
Catalog number
OXHRF3-A/B-12
Device description
"(10""-12"") Royal Flush 3 Ply Silver Heavy X-Small With Hole"
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
G296OXHRF3AB120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Stump sockA sleeve designed to be worn over a residual limb to improve contact between the stump and the socket interface of an external limb prosthesis/orthosis to: 1) provide a cushion for the alleviation of friction; 2) enable a more comfortable and stable use of the prosthesis/orthosis; and 3) function as an aid in the daily fitting of the prosthesis by an amputee patient. It is typically made of textile materials (e.g., wool, cotton). This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
009346404
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
BHRF13501100ROYLA FLUSHBHRF135-01-10BHRF135-01-102022-12-20
BHRF13501120ROYLA FLUSHBHRF135-01-12BHRF135-01-122022-12-20
BHRF13501140ROYLA FLUSHBHRF135-01-14BHRF135-01-142022-12-20
BHRF23501100ROYLA FLUSHBHRF235-01-10BHRF235-01-102022-12-20
BHRF23501120ROYLA FLUSHBHRF235-01-12BHRF235-01-122022-12-20
BHRF23501140ROYLA FLUSHBHRF235-01-14BHRF235-01-142022-12-20
BRF13501100ROYLA FLUSHBRF135-01-10BRF135-01-102022-12-20
BRF13501120ROYLA FLUSHBRF135-01-12BRF135-01-122022-12-20
BRF13501140ROYLA FLUSHBRF135-01-14BRF135-01-142022-12-20
BRF23501140ROYLA FLUSHBRF235-01-14BRF235-01-142022-12-20
G296BHRF13512100ROYAL FLUSHBHRF135-12-10BHRF135-12-102022-12-16
G296BHRF13512120ROYAL FLUSHBHRF135-12-12BHRF135-12-122022-12-16
G296BHRF13512140ROYAL FLUSHBHRF135-12-14BHRF135-12-142022-12-16
G296BHRF13523100ROYAL FLUSHBHRF135-23-10BHRF135-23-102022-12-19
G296BHRF13523120ROYAL FLUSHBHRF135-23-12BHRF135-23-122022-12-19
G296BHRF13523140ROYAL FLUSHBHRF135-23-14BHRF135-23-142022-12-19
G296BHRF13534100ROYAL FLUSHBHRF135-34-10BHRF135-34-102022-12-20
G296BHRF13534120ROYAL FLUSHBHRF135-34-12BHRF135-34-122022-12-16
G296BHRF13534140ROYAL FLUSHBHRF135-34-14BHRF135-34-142022-12-16
G296BHRF23512100ROYAL FLUSHBHRF235-12-10BHRF235-12-102022-12-19

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Primary DI, Brand, Company table
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07613378197338862T-CUSTOM ECF2 AG SoftTop UNI CaramelSIGVARIS INCFQL2026-05-18
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07613378198113862T-CUSTOM ECF2 AG SoftTop UNI GreySIGVARIS INCFQL2026-05-18
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07613378198502862T-CUSTOM ECF2 AG SoftTop UNI °° SavannaSIGVARIS INCFQL2026-05-18
07613378198892862T-CUSTOM ECF2 AG SoftTop UNI SavannaSIGVARIS INCFQL2026-05-18
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07613378199288862T-CUSTOM ECF2 AG SoftTop UNI °° SkinSIGVARIS INCFQL2026-05-18
07613378199677862T-CUSTOM ECF2 AG SoftTop UNI SkinSIGVARIS INCFQL2026-05-18
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07613378277511862T-CUSTOM ECF2 AG SoftTop UNI marineSIGVARIS INCFQL2026-05-18
07613378277900862T-CUSTOM ECF2 AG SoftTop UNI °° marineSIGVARIS INCFQL2026-05-18
08300496033981SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
08300496071099SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
08300496073109SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
08300496073116SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
08300496073123SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
08300496073130SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
08300496073147SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
07613378199295862N-CUSTOM ECF2 AG SensinovaUnisex UNI °° SkinSIGVARIS INCFQL2026-03-25
07613378196195862T-CUSTOM ECF2 AF SoftTop UNI °° BlackSIGVARIS INCFQL2026-03-18
07613378196584862T-CUSTOM ECF2 AF SoftTop UNI BlackSIGVARIS INCFQL2026-03-18
07613378196591862N-CUSTOM ECF2 AF SensinovaUnisex UNI BlackSIGVARIS INCFQL2026-03-18