FDA UDI
In Commercial Distribution
🇺🇸 United States
DeRoyal
DI: 00749756108768
·
Model: M9215
·
DEROYAL INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DeRoyal
- Primary DI
- 00749756108768
- Version / Model
- M9215
- Catalog Number
- M9215
- Company Name
- DEROYAL INDUSTRIES, INC.
- Labeler DUNS
- 096372255
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-03
- Public Version
- 1
- Public Version Date
- 2021-08-11
- Public Version Status
- New
- Public Device Record Key
- a990d51f-f338-4aa2-8f2c-5825594cf996
Device Description
WEIGHTS
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 |
|---|---|---|---|---|
| HST | Apparatus, traction, non-powered | Orthopedic | 888.5850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45534 | Vertical non-powered traction system | An assembly of devices designed to be wall-mounted for the application of constant vertical traction forces to the cervical vertebrae by means of attached harnesses. The assembly usually consists of several specialized harnesses, a combination of pulleys and cords, and a set of weights that hang from the cords as the source of the traction force (or the patient's own weight may be used). Adjustable spreader bars may be used to vary the angle at which the cord applies the traction. Patients are typically seated on a traction chair or the device may be temporarily attached to a door. The assembly is used in orthopaedic and/or physical therapy procedures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00749756108768 | GS1 |
Customer Contacts
- Phone
- +1(888)938-7828
- [email protected]