Power Knee PK230010

GUDID 05690967556822

POWER KNEE BATTERY UNIT

OSSUR AMERICAS, INC.

Knee-disarticulation prosthesis

• Primary Device ID: 05690967556822
• NIH Device Record Key: a08f2269-5553-4cb1-be91-e1c91524acbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Power Knee
• Version Model Number: PK230010
• Catalog Number: PK230010
• 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

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• 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 Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05690967556822 [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: 2018-06-11
• Device Publish Date: 2018-05-11

On-Brand Devices [Power Knee]

• 05690967603427: POWER KNEE BATT CHARGER LOANER
• 05690967603410: POWER KNEE BATTERY LOANER
• 05690967586669: POWERLOGIC II TRAINING SOFTWAR
• 05690967586652: POWERLOGIC II FULL ACCESS
• 05690967585839: POWER KNEE G2 KIT NA TRIAL
• 05690967584795: POWER KNEE G2 KIT NA 5 yr warr
• 05690967566029: POWER KNEE G2 KIT NA EUP
• 05690967556822: POWER KNEE BATTERY UNIT
• 05690967556815: POWER KNEE BATTERY CHARGER NA
• 05690967538804: POWER KNEE II LOANER
• 05690967529772: POWER KNEE G2 KIT NA
• 05690967648404: Power Knee Battery
• 05690967648381: Power Knee incl 2Y warranty
• 05690967642839: Power Knee - Trial unit
• 05690967642822: Power Knee - Loaner
• 05690967648749: Power Knee incl 3Y warranty