FDA UDI
In Commercial Distribution
🇺🇸 United States
SilverStar,Wall Mounted Overhead Pulley
DI: 00840314804723
·
Model: S-950
·
Hausmann Enterprises, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SilverStar,Wall Mounted Overhead Pulley
- Primary DI
- 00840314804723
- Version / Model
- S-950
- Company Name
- Hausmann Enterprises, LLC
- Labeler DUNS
- 001892660
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-16
- Public Version
- 1
- Public Version Date
- 2022-08-24
- Public Version Status
- New
- Public Device Record Key
- c0d09b56-cfcf-4b8f-a92f-a691990d3b4c
Device Characteristics
- Single Use
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| ION | Exerciser, Non-Measuring | Physical Medicine | 890.5370 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44231 | Upper-limb mechanical weight exerciser, lever/pulley-cable | A mechanical exercise apparatus intended primarily to strengthen the major muscles of the upper limb (e.g., biceps, triceps, deltoids, brachioradialis, wrist flexors and extensors) through a repetitive pushing, pulling, curling, or extending motion performed with the arms/hands against the force of a weight. It typically consists of a metal frame containing a lever or pulley-cable system that incorporates changeable weights and bars and/or handles/hand stirrups for the hands and arms; a bench may be included for the user to sit or lay while performing the exercise. The device may also be used to improve upper limb flexibility and mobility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840314804723 | GS1 |