FDA UDI
In Commercial Distribution
🇺🇸 United States
Kirwan
DI: 00841019116913
·
Model: 30-6023
·
KIRWAN SURGICAL PRODUCTS LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Kirwan
- Primary DI
- 00841019116913
- Version / Model
- 30-6023
- Company Name
- KIRWAN SURGICAL PRODUCTS LLC
- Labeler DUNS
- 046355210
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-07
- Public Version
- 1
- Public Version Date
- 2025-04-15
- Public Version Status
- New
- Public Device Record Key
- fc959c2a-05da-437a-834b-2a4a38d6fda1
Device Description
25cm Disposable Monopolar Electrode, Dome Tip, 1.32mm Diameter
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 |
|---|---|---|---|---|
| GXZ | Electrode, Needle | Neurology | 882.1350 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61874 | Open-surgery electrosurgical electrode, monopolar, single-use | An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10841019116910 | GS1 | 4 | In Commercial Distribution | ||
| Primary | 00841019116913 | GS1 | ||||
| Package | 20841019116917 | GS1 | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- 781-834-9500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K100912 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 25 | Centimeter |