FDA UDI
In Commercial Distribution
🇺🇸 United States
LCCS
DI: 04895233604110
·
Model: C-1010-Y-22-LC
·
LCCS Products Limited
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- LCCS
- Primary DI
- 04895233604110
- Version / Model
- C-1010-Y-22-LC
- Company Name
- LCCS Products Limited
- Labeler DUNS
- 663190222
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-23
- Public Version
- 1
- Public Version Date
- 2023-07-31
- Public Version Status
- New
- Public Device Record Key
- 256d2d99-719a-401e-bd1f-a2ad5e2b2bda
Device Description
Single-use RF Cannula
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
- Yes
- 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 |
|---|---|---|---|---|
| 58739 | Percutaneous radio-frequency ablation probe cannula, single-use | A rigid tube designed to provide percutaneous (through the skin) tissue access through its lumen for an electrosurgical probe during radio-frequency (RF) ablation procedures (typically of peripheral nerves to treat chronic pain) and for the injection/aspiration of fluids (e.g., local anaesthetic agents). It is made of metal (e.g., stainless steel), covered in insulation except for its distal tip, and includes a plastic hub; it is available in a variety of diameters and distal tip lengths/configurations. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14895233604117 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 04895233604110 | GS1 | ||||
| Package | 64895233604112 | GS1 | 40 | In Commercial Distribution |
Customer Contacts
- Phone
- +1 (844) 743-6449
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112231 | 000 |