FDA UDI
In Commercial Distribution
🇺🇸 United States
Foot and Ankle Step
DI: 60889971743619
·
Model: Foot and Ankle Step
·
CARESTREAM HEALTH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Foot and Ankle Step
- Primary DI
- 60889971743619
- Version / Model
- Foot and Ankle Step
- Catalog Number
- 1743616
- Company Name
- CARESTREAM HEALTH, INC.
- Labeler DUNS
- 793169512
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-20
- Public Version
- 3
- Public Version Date
- 2021-01-22
- Public Version Status
- Update
- Public Device Record Key
- 0487867a-84d9-49a8-94a1-3cd3a31f4a80
Device Description
FOOT AND ANKLE STEP
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| FZM | STOOL, OPERATING-ROOM | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42809 | Assistive stool/step | A platform designed or adapted for a disabled person to stand upon to compensate for differences in height, to place the feet/legs upon for rest/support when seated, and/or to sit upon. It may include legs, hand rails, and/or suction cups to attach to a surface, and may be used inside, outside or in a bath. It may be used to facilitate comfort, to correct lower-limb positioning during a treatment, or to compensate for an injury, temporary or permanent disability. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 60889971743619 | GS1 |