FDA UDI
In Commercial Distribution
🇺🇸 United States
Freeze Away Pinpoint Skin Tag Remover
DI: 10888853004836
·
Model: 90000625
·
SCHOLL'S WELLNESS COMPANY LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- Freeze Away Pinpoint Skin Tag Remover
- Primary DI
- 10888853004836
- Version / Model
- 90000625
- Catalog Number
- 90000625
- Company Name
- SCHOLL'S WELLNESS COMPANY LLC
- Labeler DUNS
- 117174744
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2025-10-01
- Public Version
- 1
- Public Version Date
- 2025-10-09
- Public Version Status
- New
- Public Device Record Key
- 38b01950-a084-4f26-a84f-fec0409ebb01
- Distribution End Date
- 2028-10-01
Device Description
Cryogenic Skin Tag Remover
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 61067 | Multiple-type neonatal pathogen nucleic acid IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with neonatal disease, in a clinical specimen using a nucleic acid technique (NAT). Microorganisms detected may include, but are not limited to, Group B Streptococcus/Streptococcus agalactiae (GBS), Listeria monocytogenes, Escherichia coli (E. coli), cytomegalovirus, Staphylococcus aureus, Chlamydia trachomatis and Ureaplasma urealyticum/parvum. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00888853004839 | GS1 | ||||
| Primary | 10888853004836 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 122 Degrees Fahrenheit