FDA UDI
In Commercial Distribution
🇺🇸 United States
Hayden Medical
DI: 00840319753422
·
Model: LC1015
·
Hayden Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Hayden Medical
- Primary DI
- 00840319753422
- Version / Model
- LC1015
- Catalog Number
- LC1015
- Company Name
- Hayden Medical, Inc.
- Labeler DUNS
- 618214410
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-26
- Public Version
- 1
- Public Version Date
- 2023-08-03
- Public Version Status
- New
- Public Device Record Key
- 2ad7404f-da1a-4e8b-8239-67890e83137c
Device Description
LLETZ Cone Electrode 10mmW x 15mmD 5.8", small, disposable
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
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 00840319753422 | GS1 | ||||
| Package | 00840319753668 | GS1 | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- 6612967200
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K091672 | 000 |