AccessGUDID - DEVICE: ROYAL FLUSH (G296OXHRF546260)

GUDID

Device Identifier (DI) Information

Brand Name: ROYAL FLUSH
Version or Model: OXHRF5-4/6-26
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OXHRF5-4/6-26
Company Name: Royal Knit, Inc.

Primary DI Number: G296OXHRF546260
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009346404 *Terms of Use

Device Description: (24"-26") Royal Flush 5 Ply Silver Heavy XX-Large With Hole

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
13635	Stump sock	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQL	Stocking, Medical Support (For General Medical Purposes)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 58439168-3328-45c8-bae0-ddad1a1a5742
Public Version Date: December 04, 2023
Public Version Number: 2
DI Record Publish Date: December 08, 2022