CLEARCUT 415-00-060

GUDID 03760177046535

TEKNIMED

Polymer orthopaedic cement restrictor, bioabsorbable

• Primary Device ID: 03760177046535
• NIH Device Record Key: 0b0331fb-745d-4813-a1f6-9d282a6a2dc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARCUT
• Version Model Number: Diameter 06
• Catalog Number: 415-00-060
• Company DUNS: 764746723
• Company Name: TEKNIMED
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760177046535 [Primary]

FDA Product Code

• LZN: Cement Obturator

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-02
• Device Publish Date: 2020-09-24

On-Brand Devices [CLEARCUT]

• 03760177046535: Diameter 06
• 03760177046696: Diameter 18
• 03760177046665: Diameter 16
• 03760177046634: Diameter 14
• 03760177046603: Diameter 12
• 03760177046573: Diameter 10
• 03760177046542: Diameter 08