STAR™

GUDID 00886385026954

Sliding Core, UHMPWE, 9mm

Stryker Trauma SA

Ankle prosthesis bearing

• Primary Device ID: 00886385026954
• NIH Device Record Key: 2e7ba6a0-dee1-4c04-890a-a2cc675a4f30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STAR™
• Version Model Number: 400-143F
• Company DUNS: 481999654
• Company Name: Stryker Trauma SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx

Device Dimensions

• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight or dampness
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight or dampness
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight or dampness
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight or dampness
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight or dampness
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight or dampness
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight or dampness
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight or dampness
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886385026954 [Primary]

FDA Product Code

• NTG: Prosthesis, Ankle, Uncemented, Non-Constrained

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-06-27

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