DEVICE: EFH-8F-W (04035479145330)

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Device Identifier (DI) Information

EFH-8F-W
401014
401014
BIOTRONIK SE & Co. KG
04035479145330
GS1
1
No description.
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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
Pacing/defibrillation lead suture sleeve A small, sterile device with a hollow centre that functions as a channel for a pacing or defibrillation lead(s), and is positioned at the point where the surgeon will suture the lead to the patient's tissue to prevent it from moving after the implantation procedure is completed. It is typically made of a silicone rubber material and is implanted with the pacemaker or defibrillator system.
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FDA Product Code

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Product Code Product Code Name
DTB permanent pacemaker Electrode
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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
October 28, 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
04035479138318 5 04035479145330 In Commercial Distribution case
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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
No
No CLOSE

Customer Contact

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