DEVICE: Click-Tip (04052838015585)
Device Identifier (DI) Information
Click-Tip
04-23-180
In Commercial Distribution
04-23-180
Medi-Globe GmbH
04-23-180
In Commercial Distribution
04-23-180
Medi-Globe GmbH
Click-Tip Injection Needle, 19 G, Needle Length 6 mm, Catheter Diameter 2.3 mm, Sheath Length 180 cm
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
Yes | |
Yes | |
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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? |
---|---|---|---|---|
38825 | General-purpose endoscopic needle, single-use |
A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FBK | Endoscopic Injection Needle, Gastroenterology-Urology |
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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Special Storage Condition, Specify: Keep dry and avoid exposure to sunlight and chemical fumes |
Storage Environment Humidity: between 30 and 60 Percent (%) Relative Humidity |
Storage Environment Temperature: between 10 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3948ce5f-b6cc-495f-8175-51c93100bfe8
March 29, 2018
2
September 21, 2016
March 29, 2018
2
September 21, 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 |
---|---|---|---|---|---|
4052838015592 | 10 | 04052838015585 | In Commercial Distribution | Box |
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
[?]
+4980329730
sales@medi-globe.de
sales@medi-globe.de