DEVICE: Rheo Knee (05690967598433)

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Device Record History
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Device Identifier (DI) Information
Rheo Knee
RKN130005
In Commercial Distribution
RKN130005
OSSUR AMERICAS, INC.
05690967598433
GS1

1
139280028 *Terms of Use
RHEO KNEE 5Y INC 40M SVC
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
41541 Knee-disarticulation prosthesis
An artificial substitute for a disarticulation amputation at the knee joint, or used in cases of limb deficiency at birth, designed as a component of an external lower-limb prosthesis to restore some of the appearance and/or function of the normal anatomy. It is typically made of metal and plastic and is typically constructed as a polycentric hinge that incorporates an upper joint section that fits against a full-length prosthetic femur. It is typically spring-assisted to control the swing of the leg.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
ISW ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXTERNAL
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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

[?]
Storage and Handling
Handling Environment Humidity: between 0 and 100 Percent (%) Relative Humidity
Handling Environment Temperature: between -10 and 40 Degrees Celsius
Storage Environment Humidity: between 0 and 100 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 45 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
cec4f74a-6926-495e-ab59-943f70b272d3
June 18, 2018
1
May 16, 2018
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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
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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