DEVICE: CLEARVAC (30653405056427)

Device Identifier (DI) Information

CLEARVAC
60-6839-001A
In Commercial Distribution
60-6839-001A
Conmed Corporation
30653405056427
GS1

10
071595540 *Terms of Use
CLEARVAC ELECTROSURGICAL SMOKE EVACUATION HANDPIECE ATTACHMENT
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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
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FDA Product Code

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Product Code Product Code Name
GEI ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Radiation Sterilization
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit
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
Handling Environment Temperature: between -34 and 65 Degrees Celsius
Handling Environment Temperature: between -29 and 149 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

cb7ad001-134d-4f27-a605-961200445abe
April 23, 2018
3
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20653405056420 10 30653405056427 In Commercial Distribution BOX
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: 00653405056426 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)237-0169
CUSTOMER_SERVICE@CONMED.COM
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