Impulse™ PSI Interbody Fusion System 17-01T

GUDID 00842048181811

Impulse™ PSI Trial

DEGEN MEDICAL, INC.

Spinal implant trial

• Primary Device ID: 00842048181811
• NIH Device Record Key: 2cd45d47-d542-4bd9-8463-5c1ae6f24e5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Impulse™ PSI Interbody Fusion System
• Version Model Number: 17-01T
• Catalog Number: 17-01T
• 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: true
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00842048181811 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241077

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00842048181811]

Moist Heat or Steam Sterilization

[00842048181811]

Moist Heat or Steam Sterilization

[00842048181811]

Moist Heat or Steam Sterilization

[00842048181811]

Moist Heat or Steam Sterilization

[00842048181811]

Moist Heat or Steam Sterilization

[00842048181811]

Moist Heat or Steam Sterilization

[00842048181811]

Moist Heat or Steam Sterilization

[00842048181811]

Moist Heat or Steam Sterilization

[00842048181811]

Moist Heat or Steam Sterilization

[00842048181811]

Moist Heat or Steam Sterilization

[00842048181811]

Moist Heat or Steam Sterilization

[00842048181811]

Moist Heat or Steam Sterilization

[00842048181811]

Moist Heat or Steam Sterilization

[00842048181811]

Moist Heat or Steam Sterilization

[00842048181811]

Moist Heat or Steam Sterilization

[00842048181811]

Moist Heat or Steam Sterilization

[00842048181811]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-21
• Device Publish Date: 2024-11-13

On-Brand Devices [Impulse™ PSI Interbody Fusion System]

• 00842048181828: Impulse™ PSI Hyperlordotic Trial
• 00842048181811: Impulse™ PSI Trial
• 00842048181767: Impulse™ PSI D Shape Spacer
• 00842048181750: Impulse™ PSI Hyperlordotic Spacer
• 00842048181743: Impulse™ PSI Contoured Spacer
• 00842048181736: Impulse™ PSI Standard Spacer