DEVICE: Provox® GuideWire (07331791000867)

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Device Identifier (DI) Information

Provox® GuideWire
7215

Atos Medical AB
07331791000867
GS1
1
The Provox GuideWire is a sterile, single use insertion device intended for placement of a sterile Provox indwelling voice prosthesis after total laryngectomy (primary or secondary puncture), or for retrograde replacement of a sterile Provox indwelling voice prosthesis.
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Device Characteristics

MR Unsafe
No
No
Yes
Yes
No
No
No
No

GMDN

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

GMDN Preferred Term Name GMDN Definition
General-purpose non-vascular guidewire A non-dedicated metal wire designed to position a catheter or similar interventional device (e.g., a dilator or an endoscope) within a lumen of the gastrointestinal (GI) tract, the tracheobronchial tree, and the urinary tract (i.e., not dedicated to either clinical application). Typically, the catheter is advanced over the wire after the wire has been manoeuvred to a treatment site (e.g., site of stent-placement). It is available in a variety of diameters and lengths, may have fluoroscopic markers, or be fitted with an introducer for entering the working channel of the catheter or other interventional device. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
EWL Prosthesis, Laryngeal (Taub)
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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
Handling Environment Temperature: between 36 and 108 Degrees Fahrenheit
Special Storage Condition, Specify: Keep dry. Keep away from sunlight.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 11, 2016

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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
No Package DIs found
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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

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+4641519800
info@atosmedical.com
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