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Royal Flush

FDA UDI

Class I (US FDA UDI)

by Royal Knit, Inc.

Identity

Trade Name
ROYAL FLUSH FDA UDI
Generic Name
Stump sock FDA UDI
Device Name
(12"-14") Royal Flush 6 Ply White Heavy X-Small/Small No Hole FDA UDI
Model / Reference
HRF6-B/0-14 FDA UDI
Description
(12"-14") Royal Flush 6 Ply White Heavy X-Small/Small No Hole FDA UDI

Identifiers

Catalog Number
HRF6-B/0-14 FDA UDI
Primary DI / UDI-DI
G296HRF6B0140 FDA UDI
FDA Product Code
FQL FDA UDI
GMDN Term
Stump sock FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5780 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Stump sock

Royal Flush is a high-quality, single-patient sleeve designed to provide comfort and stability for amputees. This sleeve is made of textile materials and features a unique design that allows it to be reapplied as needed.

Similar devices

Also classified as Stump sock.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Royal Knit, Inc.

Sources (1)

  • FDA UDI 5a3c4dc1-f23c-4c1f-8a9d-f701454bad41 34 fields · synced Aug 3, 2026