DeGen Navigated Instrumentation 15-22PC

GUDID 00842048144953

Navigated Short Open Screw Driver, Cannulated

DEGEN MEDICAL, INC.

Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable

• Primary Device ID: 00842048144953
• NIH Device Record Key: d9fcf7ef-4537-4900-9bc5-c1626cf14347
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DeGen Navigated Instrumentation
• Version Model Number: 15-22PC
• Catalog Number: 15-22PC
• Company DUNS: 078812602
• Company Name: DEGEN MEDICAL, INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com

Device Dimensions

• Length: 195.8 Millimeter
• Length: 195.8 Millimeter
• Length: 195.8 Millimeter
• Length: 195.8 Millimeter
• Length: 195.8 Millimeter
• Length: 195.8 Millimeter
• Length: 195.8 Millimeter
• Length: 195.8 Millimeter
• Length: 195.8 Millimeter
• Length: 195.8 Millimeter
• Length: 195.8 Millimeter
• Length: 195.8 Millimeter
• Length: 195.8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842048144953 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213918

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[00842048144953]

Moist Heat or Steam Sterilization

[00842048144953]

Moist Heat or Steam Sterilization

[00842048144953]

Moist Heat or Steam Sterilization

[00842048144953]

Moist Heat or Steam Sterilization

[00842048144953]

Moist Heat or Steam Sterilization

[00842048144953]

Moist Heat or Steam Sterilization

[00842048144953]

Moist Heat or Steam Sterilization

[00842048144953]

Moist Heat or Steam Sterilization

[00842048144953]

Moist Heat or Steam Sterilization

[00842048144953]

Moist Heat or Steam Sterilization

[00842048144953]

Moist Heat or Steam Sterilization

[00842048144953]

Moist Heat or Steam Sterilization

[00842048144953]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-10
• Device Publish Date: 2022-05-02

On-Brand Devices [DeGen Navigated Instrumentation]

• 00842048138860: NAVIGATED MIS SOLID SCREW DRIVER
• 00842048138853: NAVIGATED OPEN CANNULATED SCREW DRIVER
• 00842048138846: NAVIGATED MIS SOLID SCREW DRIVER
• 00842048138839: NAVIGATED MIS CANNULATED SCREW DRIVER
• 00842048138822: MIS ADAPTER DRIVER
• 00842048144960: Navigated Short Open Screw Driver, Solid
• 00842048144953: Navigated Short Open Screw Driver, Cannulated
• 00842048144946: Navigated Short Reduction Screw Driver, Solid
• 00842048144939: Navigated Short Reduction Screw Driver, Cannulated