Rheo Knee RKN130005

GUDID 05690967598433

RHEO KNEE 5Y INC 40M SVC

OSSUR AMERICAS, INC.

Knee-disarticulation prosthesis

• Primary Device ID: 05690967598433
• NIH Device Record Key: cec4f74a-6926-495e-ab59-943f70b272d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rheo Knee
• Version Model Number: RKN130005
• Catalog Number: RKN130005
• Company DUNS: 139280028
• Company Name: OSSUR AMERICAS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05690967598433 [Primary]

FDA Product Code

• ISW: ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXTERNAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-06-18
• Device Publish Date: 2018-05-16

On-Brand Devices [Rheo Knee]

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