FDA UDI
In Commercial Distribution
🇺🇸 United States
IntelliBlate Ximitry Probe Assembly, 13G x 15cm
DI: 00810563022292
·
Model: IB-XPA-1315
·
Varian Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- IntelliBlate Ximitry Probe Assembly, 13G x 15cm
- Primary DI
- 00810563022292
- Version / Model
- IB-XPA-1315
- Company Name
- Varian Medical Systems, Inc.
- Labeler DUNS
- 118097024
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-09
- Public Version
- 2
- Public Version Date
- 2025-10-06
- Public Version Status
- Update
- Public Device Record Key
- 32d76bef-6e1c-4c4c-8ddb-638bf1b55e4b
Device Description
IntelliBlate Ximitry probe assembly includes cassette with saline tubing, laser alignment disc, and microwave ablation probe 13G/15cm Probe QTY 1
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NEY | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66978 | Microwave ablation system probe, electrically-powered | An active, hand-held surgical instrument designed to connect to a microwave ablation system generator to deliver microwaves to a targeted operative site for localized soft-tissue ablation, typically to treat tumours, hydatid cysts and/or menorrhagia. The probe includes a handle and a patient contact region (e.g., antenna, leaflets), and might include a cooling mechanism (via water irrigation) and/or thermocouple(s) to help control the temperature of the probe. The device is intended to be used in percutaneous, endoscopic (e.g., gastroscopic, laparoscopic), non-surgically invasive and open surgery procedures to ablate tissues. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810563022299 | GS1 | 3 | In Commercial Distribution | ||
| Primary | 00810563022292 | GS1 | ||||
| Package | 20810563022296 | GS1 | 12 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240480 | 000 |