FDA UDI
In Commercial Distribution
🇺🇸 United States
Intracept
DI: 00852454006004
·
Model: FG 0043
·
RELIEVANT MEDSYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Intracept
- Primary DI
- 00852454006004
- Version / Model
- FG 0043
- Catalog Number
- RLV RFP05
- Company Name
- RELIEVANT MEDSYSTEMS, INC.
- Labeler DUNS
- 808344183
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-25
- Public Version
- 3
- Public Version Date
- 2023-05-03
- Public Version Status
- Update
- Public Device Record Key
- 83b0418a-8acf-4692-9ce6-4af3f3bd2b25
Device Description
Intracept RF Probe
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 |
|---|---|---|---|---|
| GXI | Probe, Radiofrequency Lesion | Neurology | 882.4725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61932 | Percutaneous radio-frequency ablation probe, denervation, bipolar | A semi-flexible, hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under x-ray, ultrasound (US) or other external image guidance] to deliver radio-frequency current, in a bipolar configuration, from a system generator directly to peripheral nerve tissues to coagulate/ablate them for the treatment of pain. It includes a distal bipolar electrode which may include temperature-sensing elements; the introduction cannula or a tubing set to allow fluid cooling of the electrode 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 | 10852454006001 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00852454006004 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 120 Degrees Fahrenheit