FDA UDI
In Commercial Distribution
🇺🇸 United States
Hurri-Freeze
DI: 10723797809447
·
Model: 35mL Mist
·
BEUTLICH PHARMACEUTICALS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Hurri-Freeze
- Primary DI
- 10723797809447
- Version / Model
- 35mL Mist
- Company Name
- BEUTLICH PHARMACEUTICALS, LLC
- Labeler DUNS
- 005209325
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-15
- Public Version
- 1
- Public Version Date
- 2025-12-23
- Public Version Status
- New
- Public Device Record Key
- 84334aa1-66fe-49ce-97f5-b4c1851a2b1d
Device Description
Hurri-Freeze Topical Anesthetic Spray - 35mL Mist
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| MLY | Vapocoolant Device | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11067 | General cryosurgical system, cryogen gas, mechanical | An assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to malignant or abnormal benign tissue for its destruction and removal. The system typically includes a mechanical regulator to control the flow of cryogen, contained in an attached cylinder, and the probe(s) to apply the cold. The system is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) and is not dedicated to ophthalmic or cardiac use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20723797809444 | GS1 | case | 24 | In Commercial Distribution | |
| Primary | 10723797809447 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232674 | 000 |