FDA UDI
In Commercial Distribution
🇺🇸 United States
Valleylab
DI: 10884524001333
·
Model: E1504
·
Covidien LP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Valleylab
- Primary DI
- 10884524001333
- Version / Model
- E1504
- Company Name
- Covidien LP
- Labeler DUNS
- 058614483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 6
- Public Version Date
- 2023-10-05
- Public Version Status
- Update
- Public Device Record Key
- a97acd05-fb85-426f-b9ba-c897a1e9723e
Device Description
Straight Extension
Device Characteristics
- Single Use
- No
- 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
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|
| 62395 | Electrosurgical electrode extension | A long, thin electrical conductor intended to extend the length of a monopolar electrosurgical electrode during an open surgical procedure. The electrode is fixed to the distal end of the device and the proximal end is attached to an electrosurgical handpiece. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10884524001333 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 34.3 | Centimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -29 – 149 Degrees Fahrenheit
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 75 Percent (%) Relative Humidity