DEVICE: SonoTip® EBUS Pro Flex (04052838011495)

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Device Identifier (DI) Information

SonoTip® EBUS Pro Flex
GUS-46-18-022
GUS-46-18-022
Medi-Globe GmbH
04052838011495
GS1
1
SonoTip EBUS Pro with Nitinol Needle, Endobronchial Ultrasound Guided TBNA System for Olympus Endoscope, 22 Gauge Needle System, Round Nitinol Stylet, Needle ø 0.7 mm, outer ø 1.8 mm, plastic sheath
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Body aspiration needle, single-use A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
FCG Biopsy Needle
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Sterilization

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

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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 Status

In Commercial Distribution
January 30, 2017

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
04052838011488 5 04052838011495 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

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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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