DEVICE: Injectra, ScleroTip (04052838009416)

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Device Record History
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Device Identifier (DI) Information
Injectra, ScleroTip
GSN-01-19-230
In Commercial Distribution
GSN-01-19-230
Medi-Globe GmbH
04052838009416
GS1

1
318130267 *Terms of Use
Injection Needle / Slerotherapy Needle , 22 Gauge, needle length 4 mm, tube diameter 1.9 mm, working length 230 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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FBK Endoscopic Injection Needle, Gastroenterology-Urology
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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

[?]
Storage and Handling
Special Storage Condition, Specify: keep dry, keep away from sunlight
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Clinically Relevant Size

[?]
Size Type Text
Needle Gauge: 22 Gauge
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Device Record Status
986aa13a-0749-44a9-88f5-61757fe3d0a6
March 29, 2018
2
June 14, 2017
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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
04052838009423 10 04052838009416 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
Yes
No CLOSE

Customer Contact

[?]
+4980329730
sales@medi-globe.de
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