FDA UDI
In Commercial Distribution
🇺🇸 United States
DeRoyal
DI: 00749756624787
·
Model: WLK02-W
·
DEROYAL INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DeRoyal
- Primary DI
- 00749756624787
- Version / Model
- WLK02-W
- Catalog Number
- WLK02-W
- Company Name
- DEROYAL INDUSTRIES, INC.
- Labeler DUNS
- 096372255
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-10
- Public Version
- 1
- Public Version Date
- 2021-08-18
- Public Version Status
- New
- Public Device Record Key
- 257f8007-b418-4ad7-9ce7-5581834bcd1d
Device Description
Folding Walker
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ITJ | WALKER, MECHANICAL | Physical Medicine | 890.3825 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37961 | Basic walking frame, foldable | A mobility aid in the form of a waist-high, foldable framework with handgrips and four, rigid, non-wheeled legs designed to provide a stable support to a person with a disability, a geriatric or an infirm person when standing or ambulating; it may also be used during rehabilitation. It is typically constructed of lightweight metal, plastic, and rubber materials and surrounds the front and flanks of the user. The user holds the handgrips and slightly lifts the device to reposition it in front of them for each forward step. The device is foldable for storage and transportation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50749756624782 | GS1 | Case | 2 | In Commercial Distribution | |
| Primary | 00749756624787 | GS1 |
Customer Contacts
- Phone
- +1(888)938-7828
- [email protected]