FDA UDI
In Commercial Distribution
🇺🇸 United States
Kirwan
DI: 00841019122020
·
Model: 12-1635AUS
·
KIRWAN SURGICAL PRODUCTS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Kirwan
- Primary DI
- 00841019122020
- Version / Model
- 12-1635AUS
- Company Name
- KIRWAN SURGICAL PRODUCTS LLC
- Labeler DUNS
- 046355210
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-06
- Public Version
- 1
- Public Version Date
- 2024-06-14
- Public Version Status
- New
- Public Device Record Key
- c4b8c9bc-4a4a-415c-8db1-7006ad495bf7
Device Description
Reusable Bipolar Forceps with Axial Bayonet, 7" Total Length, 7mm Exposed Tip Length, "NM01" Marked on the Cup, and Tips like Spetzler Tips (Tip Ends Meet First) (Special)
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 47848 | Open-surgery electrosurgical handpiece/electrode, bipolar, reusable | A rigid combined electrosurgical handpiece and bipolar 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841019122020 | GS1 |
Customer Contacts
- Phone
- 781-834-9500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K811820 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 7 | Inch |