DEVICE: Selectra (04035479116644)

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Device Identifier (DI) Information

Selectra
Accessory Kit
375518
BIOTRONIK SE & Co. KG
04035479116644
GS1
1
No description.
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Cardiac catheterization kit A collection of sterile devices designed to provide a pathway for the introduction of a device(s) (e.g., a cardiac catheter or a pacing lead) into the coronary sinus, the coronary vasculature, and the chambers of the heart. It may also be used for the percutaneous visualization of cardiac anatomy or to provide temporary occlusion during venography. The collection typically includes items such as an introducer needle or cannula, a cardiac introducer sheath or guide catheter, a dilator/obturator, a guidewire, syringes, a scalpel, and a catheter slitter. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
DQY CATHETER, PERCUTANEOUS
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 41 and 131 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
August 27, 2014

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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
No Package DIs found
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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
No
No CLOSE

Customer Contact

[?]
+1(888)345-0374
jon.brumbaugh@biotronik.com
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