FDA UDI
In Commercial Distribution
🇺🇸 United States
Equate
DI: 00194346121694
·
Model: Wart Remover
·
WAL-MART STORES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Equate
- Primary DI
- 00194346121694
- Version / Model
- Wart Remover
- Company Name
- WAL-MART STORES, INC.
- Labeler DUNS
- 051957769
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-06
- Public Version
- 1
- Public Version Date
- 2023-11-14
- Public Version Status
- New
- Public Device Record Key
- c32941bd-7ab5-44e4-9ed6-5e660195042b
Device Description
Equate Freeze Wart Remover 18 applications
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | General, Plastic Surgery | 878.4350 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42518 | Wart-removal cryogenic kit | A collection of devices designed to apply cold from a liquid/gaseous refrigerant (cryogen) to a common or plantar (sole of foot) wart for its removal. The collection typically includes a pressurized cannister with a cryogenic mixture (e.g., liquid dimethyl ether and propane), disposable applicators, a reusable activator that releases the cryogen into the applicators, and cushions; it may also include a liquid wart remover (e.g., salicylic acid) for post-cryo treatment. It is normally available [non-prescription] over-the-counter (OTC). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00194346121694 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210529 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Flammable Good Aerosol