FDA UDI
In Commercial Distribution
🇺🇸 United States
Valleylab
DI: 10884521038967
·
Model: E250510FRNSB
·
Covidien LP
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
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Basic Information
- Brand Name
- Valleylab
- Primary DI
- 10884521038967
- Version / Model
- E250510FRNSB
- Company Name
- Covidien LP
- Labeler DUNS
- 058614483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2025-03-27
- Public Version
- 3
- Public Version Date
- 2025-06-24
- Public Version Status
- Update
- Public Device Record Key
- 2a75471a-0ed3-444e-80bb-20a9dc73832d
Device Description
Valleylab Suction Coagulator 10FR/CH (3.33mm), 6" (15.24 cm) Non-Sterile Bulk
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
- Yes
- 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
- 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 20884521038964 | GS1 | ||||
| Primary | 10884521038967 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 6 | Inch | |
| Catheter Gauge | 10 | French |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 25 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -29 – 149 Degrees Fahrenheit