FDA UDI
In Commercial Distribution
🇺🇸 United States
ElectrodeCRF
DI: 00811746031452
·
Model: CRF-U2545
·
CAMBRIDGE INTERVENTIONAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ElectrodeCRF
- Primary DI
- 00811746031452
- Version / Model
- CRF-U2545
- Catalog Number
- CRF-U2545
- Company Name
- CAMBRIDGE INTERVENTIONAL LLC
- Labeler DUNS
- 080897872
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-30
- Public Version
- 2
- Public Version Date
- 2023-09-27
- Public Version Status
- Update
- Public Device Record Key
- cb12510c-0b91-4db4-a6f6-d83db91bf117
Device Description
CRF Radiofrequency Electrode
Device Characteristics
- Single Use
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61933 | Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar | A semi-flexible, hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound (US) guidance] to deliver radio-frequency current in a monopolar configuration from a system generator to coagulate/ablate tissues (excluding the CNS and heart) for the treatment of tumours (e.g., in the liver); in addition to percutaneous access it might also be intended for laparoscopic and/or open surgical use. It includes one or more distal monopolar electrode(s) which may include temperature-sensing elements; the introduction cannula may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10811746031459 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00811746031452 | GS1 |
Customer Contacts
- Phone
- 781-221-5300
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192715 | 000 |