FDA UDI
In Commercial Distribution
🇺🇸 United States
ROYAL STRETCH
DI: G296RS623120
·
Model: RS6-2/3-12
·
Royal Knit, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ROYAL STRETCH
- Primary DI
- G296RS623120
- Version / Model
- RS6-2/3-12
- Catalog Number
- RS6-2/3-12
- Company Name
- Royal Knit, Inc.
- Labeler DUNS
- 009346404
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-08
- Public Version
- 1
- Public Version Date
- 2022-07-18
- Public Version Status
- New
- Public Device Record Key
- 9cd3be4b-e86b-4405-a376-0c47977177b8
Device Description
(10"-12") Royal Stretch 6 Ply Wool Large No Hole
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| 30878 | Compression/pressure sock/stocking, single-use | A garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is intended for use in the home or a clinical setting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G296RS623120 | HIBCC |