FDA UDI
In Commercial Distribution
🇺🇸 United States
Cryo Professional
DI: 08717484792841
·
Model: UTM0200
·
Koninklijke Utermöhlen N.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cryo Professional
- Primary DI
- 08717484792841
- Version / Model
- UTM0200
- Company Name
- Koninklijke Utermöhlen N.V.
- Labeler DUNS
- 402035372
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-26
- Public Version
- 1
- Public Version Date
- 2024-07-04
- Public Version Status
- New
- Public Device Record Key
- bfce6fae-5c69-40c7-8838-c4ed64715716
Device Description
Cryo Professional Aerosol Can
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 |
|---|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | General, Plastic Surgery | 878.4350 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44724 | Cryogenic spray, cutaneous | A refrigerant (e.g., dimethyl ether and propane) typically contained in an aerosol dispenser and intended to be used to freeze superficial skin lesions (e.g., warts) for their destruction and removal. 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 | 08717484792841 | GS1 |
Customer Contacts
- Phone
- +31561693366
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152203 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 50 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store away from diathermy equipment, medical gases, and other types of incendiary sources.