FDA UDI
In Commercial Distribution
🇺🇸 United States
ROYAL FLUSH
DI: G296RF8AB100
·
Model: RF8-A/B-10
·
Royal Knit, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ROYAL FLUSH
- Primary DI
- G296RF8AB100
- Version / Model
- RF8-A/B-10
- Catalog Number
- RF8-A/B-10
- Company Name
- Royal Knit, Inc.
- Labeler DUNS
- 009346404
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-14
- Public Version
- 2
- Public Version Date
- 2023-12-04
- Public Version Status
- Update
- Public Device Record Key
- cdf7a1f3-f535-4ac4-bb89-1c45b668589a
Device Description
(8"-10") Royal Flush 8 Ply White X-Small No Hole
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FQL | Stocking, Medical Support (For General Medical Purposes) | General Hospital | 880.5780 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G296RF8AB100 | HIBCC |