FDA UDI
In Commercial Distribution
🇺🇸 United States
A&E Medical / Disposable Suction Coagulator
DI: 10841291104940
·
Model: 050-035
·
A & E MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- A&E Medical / Disposable Suction Coagulator
- Primary DI
- 10841291104940
- Version / Model
- 050-035
- Company Name
- A & E MEDICAL CORPORATION
- Labeler DUNS
- 173770868
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-23
- Public Version
- 4
- Public Version Date
- 2019-02-07
- Public Version Status
- Update
- Public Device Record Key
- 850b884b-f61b-404f-b666-e23523fae929
Device Description
Suction Coagulator, 1 per pouch
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| 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 | 20841291104947 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 10841291104940 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K881413 | 000 |