DEVICE: GOLDVAC (30653405061209)
Device Identifier (DI) Information
GOLDVAC
60-7580-005
In Commercial Distribution
60-7580-005
Conmed Corporation
60-7580-005
In Commercial Distribution
60-7580-005
Conmed Corporation
GOLDVAC ROCKER SWITCH, 15', ELECTROSURGICAL SMOKE EVACUAION HANDPIECE
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Surgical plume evacuation system | A mains electricity (AC-powered) assembly of devices intended to capture smoke generated during open surgical procedures involving tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). It captures the plume (smoke composed of carbonized cell fragments, water vapour, and hydrocarbons from vaporized tissue) near its origin before it becomes dispersed and causes surgical staff respiratory exposure. It consists of a capture tube or wand and four elements to evacuate smoke: user interface, filters, suction source, and exhaust. The system may be mobile (on wheels) and used during closed surgical procedures (e.g., endoscopy, laparoscopy) to clear the view. See also: Gas/fume evacuation system; Anaesthetic gas scavenging unit; Suction system filter, plume particulate; Orthopaedic cement fume evacuator; Surgical plume evacuation system tube |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between -40 and 158 Degrees Fahrenheit |
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit |
Handling Environment Temperature: between -40 and 70 Degrees Celsius |
Handling Environment Humidity: between 5 and 50 Percent (%) Relative Humidity |
Storage Environment Temperature: between 10 and 32 Degrees Celsius |
Storage Environment Humidity: between 5 and 70 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
18158d6d-64de-48bc-bd3b-2179bfb263be
April 23, 2018
3
September 24, 2016
April 23, 2018
3
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 |
---|---|---|---|---|---|
20653405061202 | 10 | 30653405061209 | In Commercial Distribution | BOX |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00653405061208
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)237-0169
CUSTOMER_SERVICE@CONMED.COM
CUSTOMER_SERVICE@CONMED.COM