FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CVS Health
DI: 00050428542637
·
Model: 717272
·
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CVS Health
- Primary DI
- 00050428542637
- Version / Model
- 717272
- Catalog Number
- 717272
- Company Name
- WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- Labeler DUNS
- 062312574
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 4
- Public Version Date
- 2018-07-12
- Public Version Status
- Update
- Public Device Record Key
- 263b09e3-f5ba-4f8f-8abb-7080a8663174
- Distribution End Date
- 2016-10-07
Device Description
Ready to Use Wart Freezer Cryogenic Treatment
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 |
|---|---|---|---|---|---|---|
| Package | 10050428542634 | GS1 | Case | 6 | Not in Commercial Distribution | 2016-10-07 |
| Primary | 00050428542637 | GS1 |
Customer Contacts
- Phone
- 941-378-6658
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 155 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- 20-25 Degrees Celsius