Dynafit System S21TL12

GUDID 33701173702767

Self compressive screw

NEOSTEO

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 33701173702767
• NIH Device Record Key: 60069be4-75e7-4e58-8bd0-0e018b469d5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dynafit System
• Version Model Number: S21TL12
• Catalog Number: S21TL12
• Company DUNS: 261106831
• Company Name: NEOSTEO
• Device Count: 1
• DM Exempt: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	33701173702767 [Primary]

FDA Product Code

• HWC: Screw, Fixation, Bone

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: 2018-07-30
• Device Publish Date: 2018-06-28

On-Brand Devices [Dynafit System]

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• 33701173702958: Snap-off self compressive screw
• 33701173702941: Snapp-off self compressive screw
• 33701173702934: Snapp-off self compressive screw
• 33701173702927: Snap off self compressive screw
• 33701173702903: Self compressive screw
• 33701173702897: Self compressive screw
• 33701173702880: Self compressive screw
• 33701173702873: Self compressive screw
• 33701173702866: Self compressive screw
• 33701173702859: Self compressive screw
• 33701173702842: Self compressive screw
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• 33701173702804: Self compressive screw
• 33701173702798: Self compressive screw
• 33701173702781: Self compressive screw
• 33701173702774: Self compressive screw
• 33701173702767: Self compressive screw
• 33701173702743: Self compressive screw