FDA UDI
In Commercial Distribution
🇺🇸 United States
BIONEN
DI: 08033315122664
·
Model: 0028527
·
BIONEN SAS DI BARBARA NENCIONI & C.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BIONEN
- Primary DI
- 08033315122664
- Version / Model
- 0028527
- Company Name
- BIONEN SAS DI BARBARA NENCIONI & C.
- Labeler DUNS
- 444022750
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-04
- Public Version
- 1
- Public Version Date
- 2018-10-05
- Public Version Status
- New
- Public Device Record Key
- 02d9295e-966e-4c0b-ad5d-a68b1cc174d7
Device Description
Hypodermic Needle Electrode for Botox injection (disposable)
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
- 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 |
|---|---|---|---|---|
| IKT | Electrode, Needle, Diagnostic Electromyograph | Physical Medicine | 890.1385 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11441 | Electromyographic needle electrode, single-use | A sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033315122664 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092973 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 33 | Millimeter | |
| Needle Gauge | 28 | Gauge |