Rheo Knee RKN130005

GUDID 05690967598433

RHEO KNEE 5Y INC 40M SVC

OSSUR AMERICAS, INC.

Knee-disarticulation prosthesis
Primary Device ID05690967598433
NIH Device Record Keycec4f74a-6926-495e-ab59-943f70b272d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameRheo Knee
Version Model NumberRKN130005
Catalog NumberRKN130005
Company DUNS139280028
Company NameOSSUR AMERICAS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105690967598433 [Primary]

FDA Product Code

ISWASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXTERNAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-06-18
Device Publish Date2018-05-16

On-Brand Devices [Rheo Knee]

05690977467873RHEO KNEE XC TRIAL UNIT
05690977467811RHEO KNEE XC 5YWARR incl 40MSC
05690977467804RHEO KNEE XC 3 YRS WARRANTY
05690977467798RHEO KNEE XC 2 YRS WARRANTY
05690977279728RHEOIII KNEE WP TRIAL W LOCK
05690967613136RHEO KNEE XC LOANER
05690967610517RHEO KNEE 3 WP Loaner
05690967600600RHEO KNEE 3 TRIAL
05690967600594RHEO KNEE 3 W LOCK TRIAL
05690967600587RHEO KNEE 3 W LOCK LOANER
05690967598433RHEO KNEE 5Y INC 40M SVC
05690967598426RHEO KNEE 2YRS WARRANTY
05690967596644RHEO KNEE 3 LOANER
05690967595425RHEO KNEE 3 Trials
05690967595418RHEO KNEE 3YRS WARRANTY
05690967566227RHEOLOGIC WORKBENCH PC 4.0.1
05690967529864RHEO KNEE LOANER
05690967514341KIT POWERSUPPLY PROPRIO/RHEO

Trademark Results [Rheo Knee]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RHEO KNEE
RHEO KNEE
78355206 3114942 Live/Registered
Ossur HF
2004-01-21

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