FDA UDI
In Commercial Distribution
🇺🇸 United States
ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, Ellipsoidal
DI: 00810563022032
·
Model: PC-2.1E
·
VARIAN MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, Ellipsoidal
- Primary DI
- 00810563022032
- Version / Model
- PC-2.1E
- Company Name
- VARIAN MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 009120817
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-20
- Public Version
- 5
- Public Version Date
- 2023-08-03
- Public Version Status
- Update
- Public Device Record Key
- eafe1d89-5dc8-4427-a1a9-24034fb6de6a
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
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 |
|---|---|---|---|---|
| 45140 | Cryosurgical set | A sterile collection of disposable devices used in conjunction with a cryosurgical unit as well as monitoring and other devices to perform a surgical technique that involves freezing a targeted area of tissue to damage and destroy cancer cells in the unwanted portions. A typical set will contain cryo needles, thermal sensors, warmer tubes and catheters, warmer cassette, and tube holders. It is typically used for early stages of prostate cancer or late recurrence of localized prostate cancer after radiotherapy where the prostate is cooled to a temperature of -40° Celsius. Warming of the areas where freezing is not required is simultaneously carried out. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810563022032 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230271 | 000 |