DEVICE: SonoTip Pro Control (04052838014083)

Device Identifier (DI) Information

SonoTip Pro Control
GUS-33-27-025-04
In Commercial Distribution
GUS-33-27-025-04
Medi-Globe GmbH
04052838014083
GS1

1
318130267 *Terms of Use
SonoTip Pro Control Endoscopic Ultrasound Needle, EUS-FNA, 25 G, Needle Length 0 - 8.5 cm, Sheath Diameter 2.7 mm, round stylet
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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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
10403 Ultrasound aspiration biopsy procedure kit
A collection of sterile devices that includes a biopsy needle and other supplies used to perform an ultrasound-guided aspiration sampling of tissue. The needle tip must provide a clearly visible image during ultrasound imaging. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FCG Biopsy Needle
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Please store the instrument at room temperature, keep dry and avoid exposure to sunlight
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Clinically Relevant Size

[?]
Size Type Text
Needle Gauge: 25 Gauge
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Device Record Status

7343565b-592f-4202-8fbd-bd67d2a6f981
March 29, 2018
2
September 23, 2016
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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
4052838014090 5 04052838014083 In Commercial Distribution Box
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Secondary DI

[?]
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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