DEVICE: Valleylab (10884521740860)
Device Identifier (DI) Information
Valleylab
SEL7010
In Commercial Distribution
Covidien LP
SEL7010
In Commercial Distribution
Covidien LP
Laparoscopic Smoke Evacuation System Active and Passive
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
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? |
---|---|---|---|---|
60836 | Laparoscopic plume filter |
A sterile device intended to be used during minimally-invasive surgery, in particular laparoscopic surgery, to filter surgical smoke (plume created by, e.g., electrosurgical diathermy, a laser or sonic scalpel) of potentially harmful agents (e.g., noxious chemicals, particulates, viruses, bacteria) without loss of pneumoperitoneum. It is typically a multi-layered filter pouch intended to be connected to a trocar stopcock; it is intended to help protect surgical staff from ambient exposure to potentially harmful agents. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NKC | Tubing/tubing with filter, insufflation, laparoscopic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep dry. |
Handling Environment Temperature: between -20 and 140 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
71df30df-227d-403d-92fc-8ef24defedc9
June 24, 2025
6
September 03, 2020
June 24, 2025
6
September 03, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20884521740867 | 10 | 10884521740860 | 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