DEVICE: MEGADYNE (10614559104651)
Device Identifier (DI) Information
MEGADYNE
2403J
In Commercial Distribution
2403J
MEGADYNE MEDICAL PRODUCTS, INC.
2403J
In Commercial Distribution
2403J
MEGADYNE MEDICAL PRODUCTS, INC.
Megadyne Smoke Evacuator Connect Cable, 1m
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
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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 |
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FYD | APPARATUS, EXHAUST, SURGICAL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K200250 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Storage Environment Temperature: between 5 and 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
4773383a-eb1a-4f29-be57-1f2c1313a387
June 11, 2021
5
August 03, 2020
June 11, 2021
5
August 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 |
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30614559104655 | 10 | 10614559104651 | In Commercial Distribution | BOX |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined