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
GUS-33-27-025-04
In Commercial Distribution
GUS-33-27-025-04
Medi-Globe GmbH
SonoTip Pro Control Endoscopic Ultrasound Needle, EUS-FNA, 25 G, Needle Length 0 - 8.5 cm, Sheath Diameter 2.7 mm, round stylet
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FCG | Biopsy Needle |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Please store the instrument at room temperature, keep dry and avoid exposure to sunlight |
Clinically Relevant Size
[?]Size Type Text |
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Needle Gauge: 25 Gauge |
Device Record Status
7343565b-592f-4202-8fbd-bd67d2a6f981
March 29, 2018
2
September 23, 2016
March 29, 2018
2
September 23, 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 |
---|---|---|---|---|---|
4052838014090 | 5 | 04052838014083 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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