FDA.report

ROYAL FLUSH

Primary DI
G296OBHRF5AB180
Brand
ROYAL FLUSH
Company
Royal Knit, Inc.
Model
OBHRF5-A/B-18
Catalog number
OBHRF5-A/B-18
Device description
(16"-18") Royal Flush 5 Ply Black Heavy X-Small With Hole
Published
2022-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FQLStocking, Medical Support (For General Medical Purposes)

Product Code Classifications

CodeDeviceSpecialtyClass
FQLStocking, Medical Support (For General Medical Purposes)General Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G296OBHRF5AB180PrimaryHIBCC0

GMDN Terms

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

Regulatory Flags

DUNS number
009346404
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08300496072157SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072164SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072171SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072188SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072195SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072201SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072218SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072225SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072232SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072331SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072348SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072355SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072362SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072379SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072386SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072393SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072409SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072416SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072423SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072430SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072447SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072454SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072461SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072478SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072485SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072492SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072508SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072515SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072522SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072539SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20