FDA UDI
In Commercial Distribution
🇺🇸 United States
Renew Smoothing Cream
DI: 00745129219062
·
Model: 570F
·
SIGVARIS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Renew Smoothing Cream
- Primary DI
- 00745129219062
- Version / Model
- 570F
- Catalog Number
- 570F200
- Company Name
- SIGVARIS INC
- Labeler DUNS
- 189738719
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-05
- Public Version
- 5
- Public Version Date
- 2025-07-14
- Public Version Status
- Update
- Public Device Record Key
- 5cb81f28-588a-4a6e-ac54-f9542fbc69ef
Device Description
A cream designed to soften and smooth the skin on the foot, including assisting the removal of calluses and dry skin. This cream is diabetic safe, hypoallergenic and unscented.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| IKX | Aid, Transfer | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58851 | Massage oil/cream/gel | A non-sterile substance intended to be applied to the skin and/or external mucosa to facilitate therapeutic massage, such as massage to treat musculoskeletal injury, perineal massage during pregnancy, or breast massage to help reduce the painful symptoms of mastodynia (breast tension). It is in the form of a gel, cream, or ointment intended to lubricate tissues during massage, and possibly help increase tissue elasticity and flexibility. It is typically available [non-prescription] over-the-counter for use in the home and healthcare facility. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00745129219062 | GS1 |
Customer Contacts
- Phone
- +1(800)322-7744
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | No Device Sizes |