FDA UDI
In Commercial Distribution
🇺🇸 United States
iovera
DI: 00816287020248
·
Model: IST2221
·
Pacira Pharmaceuticals, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- iovera
- Primary DI
- 00816287020248
- Version / Model
- IST2221
- Company Name
- Pacira Pharmaceuticals, Inc.
- Labeler DUNS
- 117399934
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-13
- Public Version
- 2
- Public Version Date
- 2023-07-17
- Public Version Status
- Update
- Public Device Record Key
- bb5d0f18-4634-4f83-bda0-0f436258a014
Device Description
SYSTEM FALCON IOVERA US
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GXH | Device, Surgical, Cryogenic | Neurology | 882.4250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45738 | General cryosurgical system, cryogen gas, electronic | An assembly of electrically-powered 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 destruction and removal. The system includes an electronic control unit with LCD display to control the flow of cryogen from an attached cylinder, which might monitor skin temperature, and cryogen-cooled probes. It is intended for e.g., oncological, dermatological, oral, gynaecological, urological, proctological, or general surgical applications, however it is not dedicated to ophthalmic or cardiac surgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816287020248 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211334 | 000 |