DEVICE: Tennafix™ (05414734400749)

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Device Identifier (DI) Information

Tennafix™
1205
1205
ST. JUDE MEDICAL, INC.
05414734400749
GS1
1
Adhesive Pads
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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
Cable/lead skin-adherent patch A non-sterile adhesive patch intended to loosely secure a cable/lead to a patient’s body, to minimize the risk of loosening or detachment of the lead from the patient or operating device. It is typically in the form of a fastening loop, to hold the cable/lead, attached to a self-adhesive patch which makes contact with the skin. It has no electrical or conducting components or properties and is made of synthetic polymer materials. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
LGW STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Handling Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 150 KiloPascal
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 150 KiloPascal
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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 08, 2015

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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
15414734400746 100 05414734400749 2016-11-11 Not in Commercial Distribution
35414734400740 5 25414734400743 In Commercial Distribution
25414734400743 20 05414734400749 In Commercial Distribution
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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

[?]
+1(855)478-5833
customerservice@sjm.com
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