FDA UDI
In Commercial Distribution
🇺🇸 United States
Sonablate Insertion Pack
DI: 00868108000267
·
Model: 403-02200-0014
·
FOCUS SURGERY INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sonablate Insertion Pack
- Primary DI
- 00868108000267
- Version / Model
- 403-02200-0014
- Company Name
- FOCUS SURGERY INC
- Labeler DUNS
- 101084143
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-24
- Public Version
- 3
- Public Version Date
- 2019-02-08
- Public Version Status
- Update
- Public Device Record Key
- 797987a4-3b25-4018-b9b6-84f334183c27
Device Description
A combination kit consisting 1 Water Path Kit and 1 Sonablate Probe Tip Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| PLP | High Intensity Ultrasound System For Prostate Tissue Ablation | Gastroenterology, Urology | 876.4340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40781 | Ultrasonic hyperthermia system | An assembly of devices designed to produce and control the delivery of high heat (i.e., temperatures greater than 43? Celsius) to the body using ultrasonic energy for the intracorporeal or extracorporeal treatment of malignant or benign tumours, or other disease conditions. It is typically computer-controlled and is capable of producing whole-body or localized heating within tissues or organs. Energy delivered to the patient is from either an externally-mounted transducer or a transducer-containing catheter or probe used topically or inserted endoscopically or surgically. Unlike an ultrasound diathermy system, an ultrasound hyperthermia system is not used in physiotherapy applications. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00868108000267 | GS1 |