FDA UDI
In Commercial Distribution
🇺🇸 United States
Steady Step
DI: 00082161502043
·
Model: 50204
·
BROWNMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Steady Step
- Primary DI
- 00082161502043
- Version / Model
- 50204
- Company Name
- BROWNMED, INC.
- Labeler DUNS
- 091999771
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-18
- Public Version
- 1
- Public Version Date
- 2020-08-26
- Public Version Status
- New
- Public Device Record Key
- e0c9e28a-5404-4f1c-b6a2-7f9a318a0b53
Device Description
Steady Step® Toehold®
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| ISH | Component, External, Limb, Ankle/Foot | Physical Medicine | 890.3420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63931 | Toe intraoperative aligner | A non-sterile, flat, metal sheet intended to be used to align a toe during a metatarsophalangeal arthrodesis. It is placed against the sole of the foot to provide a flat reference point for supporting the toe in the correct position. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00082161502043 | GS1 |