FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MytaMed
DI: 00841019110232
·
Model: 40-6000
·
Mytamed, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- MytaMed
- Primary DI
- 00841019110232
- Version / Model
- 40-6000
- Company Name
- Mytamed, Inc.
- Labeler DUNS
- 015903922
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-10
- Public Version
- 5
- Public Version Date
- 2025-06-25
- Public Version Status
- Update
- Public Device Record Key
- 88505271-7dbe-4258-a4e0-4105d68ade37
- Distribution End Date
- 2024-12-31
Device Description
Single Use Monopolar Suction Coagulator 10 French with 10 ft (3m) Monopolar 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
- No
- 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
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HAM | Apparatus, Electrosurgical | General, Plastic Surgery | 878.4400 | 2 |
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 | 20841019110236 | GS1 | 50 | Not in Commercial Distribution | 2024-12-31 | |
| Primary | 00841019110232 | GS1 | ||||
| Package | 10841019110239 | GS1 | 10 | Not in Commercial Distribution | 2024-12-31 |
Customer Contacts
- Phone
- 781-834-9500
- [email protected]
- Phone
- 781-834-9500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K895337 | 000 |