FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: H671ESU3060
·
Model: N/A
·
UTAH MEDICAL PRODUCTS, INC.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- N/A
- Primary DI
- H671ESU3060
- Version / Model
- N/A
- Catalog Number
- ESU-306
- Company Name
- UTAH MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 094651270
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 5
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- f243efa1-8cf2-4c5e-b8d6-baab3235c080
Device Description
Disposable Electrosurgical Pencil for Footswitch Operation, with 10' 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
| HGI | Electrocautery, Gynecologic (And Accessories) | Obstetrics/Gynecology | 884.4120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44681 | Electrosurgical handpiece, single-use | A hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to a generator; it is not intended for use during inert gas-enhanced electrosurgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | H671ESU3062 | HIBCC | 4 | In Commercial Distribution | ||
| Package | H671ESU3061 | HIBCC | 10 | In Commercial Distribution | ||
| Primary | H671ESU3060 | HIBCC |
Customer Contacts
- Phone
- 800-533-4984
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Fits 3/32" Diameter Shaft Electrodes |