DEVICE: Single Use Professional (05055299106051)
Device Identifier (DI) Information
Single Use Professional
S435
In Commercial Distribution
S435
EAKIN SURGICAL LIMITED
S435
In Commercial Distribution
S435
EAKIN SURGICAL LIMITED
Lipped Suction 12fg 12cm contains 25 units
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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64120 | Surgical irrigation/aspiration cannula, non-illuminating, single-use |
An atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (typically laparoscopy), usually to facilitate observation. It is not dedicated to dental or intrauterine procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It might incorporate a handle with a valve(s) and hole(s) on its side for the control of irrigation/aspiration, and may be provided with a stylet, a sheath, and/or connection tubing; it is typically made of metal. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Length: 12 Centimeter |
Catheter Gauge: 12 French |
Angle: 60 degree |
Device Record Status
a1aaf9c9-b75f-47ba-a5af-8fef4ea64fd4
April 08, 2024
8
August 09, 2016
April 08, 2024
8
August 09, 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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
No Customer Contact currently defined