FDA UDI
In Commercial Distribution
🇺🇸 United States
Kirwan
DI: 00841019115756
·
Model: 19-8010C
·
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
- 00841019115756
- Version / Model
- 19-8010C
- Company Name
- KIRWAN SURGICAL PRODUCTS LLC
- Labeler DUNS
- 046355210
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-04
- Public Version
- 1
- Public Version Date
- 2025-04-14
- Public Version Status
- New
- Public Device Record Key
- 2f62e38b-546f-4ea2-8eb9-9b2ffd985a80
Device Description
8 1/2" Disposable Monopolar Potts-Smith, Insulated, 1.5mm Tip with 10ft. Cord
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 |
|---|---|---|---|---|
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61869 | Open-surgery electrosurgical handpiece/electrode, monopolar, single-use | A rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. 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 | 10841019115753 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00841019115756 | GS1 | ||||
| Package | 20841019115750 | GS1 | 50 | In Commercial Distribution |
Customer Contacts
- Phone
- 781-834-9500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K872271 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8.5 | Inch |