DEVICE: ZIP Pen (10614559105757)

Device Identifier (DI) Information

ZIP Pen
2560J
In Commercial Distribution
2560J
MEGADYNE MEDICAL PRODUCTS, INC.
10614559105757
GS1

1
185444825 *Terms of Use
Zip Pen Extension Nozzle 5.2" (13.2 cm)
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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?
37861 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
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GEI Electrosurgical, Cutting & Coagulation & Accessories
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K141587 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 5 and 50 Degrees Celsius
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

a9a1cca9-a11a-4c89-83b4-ae5486be981b
June 11, 2021
7
September 04, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
50614559105755 80 10614559105757 In Commercial Distribution CASE
30614559105751 10 10614559105757 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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found 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(801)576-9669
megadyne.udi@megadyne.com
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