DEVICE: HUMAC NORM (R) (00860139000315)

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Device Identifier (DI) Information

HUMAC NORM (R)
504191
504191
COMPUTER SPORTS MEDICINE INC.
00860139000315
GS1
1
HUMAC NORM Extremity System; Dynamometer – Refurbished
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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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
Back/leg/chest dynamometer An analogue instrument designed to assess neuromuscular function by measuring the force or power exerted by the back, chest, and leg muscles during flexion. It includes a force gauge, which may be attached to a handle or strap, to assess a variety of movements (e.g., leg abduction, lifting) and is typically used to test and control a patient's muscle strength as part of a rehabilitation program.
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FDA Product Code

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Product Code Product Code Name
IKK System, Isokinetic Testing And Evaluation
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Sterilization

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

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Storage and Handling
Special Storage Condition, Specify: Relative Humidity for Storage and Handling is noncondensing
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between -10 and 55 Degrees Celsius
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
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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 14, 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)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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781-297-2034
dev@csmisolutions.com
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