FDA UDI
In Commercial Distribution
🇺🇸 United States
Ion Coagulation Pen
DI: B9122025302
·
Model: 202530
·
ION MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Ion Coagulation Pen
- Primary DI
- B9122025302
- Version / Model
- 202530
- Company Name
- ION MEDICAL, INC.
- Labeler DUNS
- 020795679
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2020-06-08
- Public Version
- 1
- Public Version Date
- 2020-06-16
- Public Version Status
- New
- Public Device Record Key
- 7768986f-78b1-42ca-ab78-7dcd51c0baf4
Device Description
25 Gauge Fine Point Bipolar Coagulation Pen
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 |
|---|---|---|---|---|
| 57944 | Endoscopic electrosurgical handpiece/electrode, bipolar, single-use | A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery; it is not intended for focal percutaneous ablation. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | B91220253001 | HIBCC | ||||
| Primary | B9122025302 | HIBCC |
Customer Contacts
- Phone
- 1-800-785-7202
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K072911 | 000 |