DeGen Navigated Instrumentation 15-21P

GUDID 00842048138860

NAVIGATED MIS SOLID SCREW DRIVER

DEGEN MEDICAL, INC.

Surgical screwdriver, reusable

• Primary Device ID: 00842048138860
• NIH Device Record Key: 247c3336-bac4-4b45-9c70-581af5f7f346
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DeGen Navigated Instrumentation
• Version Model Number: 15-21P
• Catalog Number: 15-21P
• 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

Device Dimensions

• Length: 238.55 Millimeter
• Length: 238.55 Millimeter
• Length: 238.55 Millimeter
• Length: 238.55 Millimeter
• Length: 238.55 Millimeter
• Length: 238.55 Millimeter
• Length: 238.55 Millimeter
• Length: 238.55 Millimeter
• Length: 238.55 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842048138860 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203816

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[00842048138860]

Moist Heat or Steam Sterilization

[00842048138860]

Moist Heat or Steam Sterilization

[00842048138860]

Moist Heat or Steam Sterilization

[00842048138860]

Moist Heat or Steam Sterilization

[00842048138860]

Moist Heat or Steam Sterilization

[00842048138860]

Moist Heat or Steam Sterilization

[00842048138860]

Moist Heat or Steam Sterilization

[00842048138860]

Moist Heat or Steam Sterilization

[00842048138860]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-30
• Device Publish Date: 2021-08-20

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
• 00842048155355: Navigated Modular Screw Driver, T25, Solid
• 00842048155348: Navigated Modular Screw Driver, T25, Cannulated