DEVICE: Valleylab (10884524002002)
Device Identifier (DI) Information
Valleylab
E2771-36
Not in Commercial Distribution
Covidien LP
E2771-36
Not in Commercial Distribution
Covidien LP
Laparoscopic Curved Spatula Electrode,Solid
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
58039 | Endoscopic electrosurgical handpiece/electrode, monopolar, single-use |
An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and requires a patient contact return electrode; it may include a suction/irrigation lumen and may feature a magnetic guidance sensor for electromagnetic tracking. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe) and may also be designed to mechanically cut tissues. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K904560 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between -29 and 149 Degrees Fahrenheit |
Handling Environment Humidity: between 0 and 75 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 36 Centimeter |
Device Record Status
d59f7494-3d46-468c-a135-9b0f6cb4d864
June 30, 2025
11
September 24, 2016
June 30, 2025
11
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20884524002009 | 10 | 10884524002002 | 2025-06-25 | Not in Commercial Distribution | PACK_OR_INNER_PACK |
30884524002006 | 25 | 20884524002009 | 2025-06-25 | Not in Commercial Distribution | CASE |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(508)261-8000
covidien.udi@covidien.com
covidien.udi@covidien.com