DEVICE: EFH-16 (04035479144821)

Device Identifier (DI) Information

EFH-16
115489
In Commercial Distribution
115489
BIOTRONIK SE & Co. KG
04035479144821
GS1

1
315620229 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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FDA Premarket Submission

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

Sterilization

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

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

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Size Type Text
No Device Sizes
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Device Record Status

a8c9ebc1-48a6-4484-ba36-14629f5c85df
March 29, 2018
2
August 14, 2014
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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
04035479002916 10 04035479144821 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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