FDA.reportPublic FDA data

ROYAL FLUSH

Primary DI
G296BHRF3B0220
Brand
ROYAL FLUSH
Company
Royal Knit, Inc.
Model
BHRF3-B/0-22
Catalog number
BHRF3-B/0-22
Device description
"(20""-22"") Royal Flush 3 Ply Black Heavy X-Small/Small No Hole"
Published
2022-09-21
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
G296BHRF3B0220PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Stump sockA device that is designed to be worn over a residual limb to provide a cushion for the alleviation of friction between the skin and socket interface of the prosthesis/orthosis. It is typically made from wool or 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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