FDA UDI
In Commercial Distribution
🇺🇸 United States
CryoClear
DI: 00850077006043
·
Model: 161-2001
·
CRYOCONCEPTS, LP
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CryoClear
- Primary DI
- 00850077006043
- Version / Model
- 161-2001
- Catalog Number
- 161-2001
- Company Name
- CRYOCONCEPTS, LP
- Labeler DUNS
- 038024868
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- fb554e72-98f5-4ab4-8db9-bd2c3dbaa27a
Device Description
The CryoClear™ is a multi-use disposable device intended for the removal of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the types of lesions that can be treated. • Lentigo (Age Spots) • Skin Tags • Actinic Keratosis (Sun Spots) • Acne (Cysts & Scars) • Angiomas • Spider Angiomas • Teleangiectases • Keratosis Pilaris (Milia) • Sebaceous Hyperplasia
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
- Yes
- Has Expiration Date
- No
- 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 | 00850077006043 | GS1 | ||||
| Package | 10850077006040 | GS1 | Box | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-855-355-2796
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102006 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 16 | Gram |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect the device from direct sunlight.
- Type
- Handling Environment Temperature
- Temperature Range
- – 65 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- – 65 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store device away from heat or potential sources of heat.