Impulse Interbody Spacer System 07-36T1022N

GUDID 00842048147015

10H x 22L x 12W Impulse Neutral Modular Trial

DEGEN MEDICAL, INC.

Spinal implant trial

• Primary Device ID: 00842048147015
• NIH Device Record Key: c6b3ddd2-3135-488b-8d89-d6c85f3ca2fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Impulse Interbody Spacer System
• Version Model Number: 07-36T1022N
• Catalog Number: 07-36T1022N
• 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
• 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

• Width: 12 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Width: 12 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Width: 12 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Width: 12 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Width: 12 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Width: 12 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Width: 12 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Width: 12 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Width: 12 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Width: 12 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Width: 12 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Width: 12 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Width: 12 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Width: 12 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Width: 12 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Width: 12 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Width: 12 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842048147015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201287

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00842048147015]

Moist Heat or Steam Sterilization

[00842048147015]

Moist Heat or Steam Sterilization

[00842048147015]

Moist Heat or Steam Sterilization

[00842048147015]

Moist Heat or Steam Sterilization

[00842048147015]

Moist Heat or Steam Sterilization

[00842048147015]

Moist Heat or Steam Sterilization

[00842048147015]

Moist Heat or Steam Sterilization

[00842048147015]

Moist Heat or Steam Sterilization

[00842048147015]

Moist Heat or Steam Sterilization

[00842048147015]

Moist Heat or Steam Sterilization

[00842048147015]

Moist Heat or Steam Sterilization

[00842048147015]

Moist Heat or Steam Sterilization

[00842048147015]

Moist Heat or Steam Sterilization

[00842048147015]

Moist Heat or Steam Sterilization

[00842048147015]

Moist Heat or Steam Sterilization

[00842048147015]

Moist Heat or Steam Sterilization

[00842048147015]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-29
• Device Publish Date: 2021-12-21

On-Brand Devices [Impulse Interbody Spacer System]

• 00842048138334: 12mm Impulse Hyperlordotic Inserter
• 00842048138327: 10mm Impulse Hyperlordotic Inserter
• 00842048138310: 8mm Impulse Hyperlordotic Inserter
• 00842048137535: 16H X 36L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137528: 15H X 36L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137511: 14H X 36L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137504: 13H X 36L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137498: 12H X 36L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137481: 11H X 36L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137474: 10H X 36L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137467: 9H X 36L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137450: 16H X 32L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137443: 15H X 32L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137436: 14H X 32L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137429: 13H X 32L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137412: 12H X 32L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137405: 11H X 32L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137399: 10H X 32L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137382: 9H X 32L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137375: 16H X 26L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137368: 15H X 26L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137351: 14H X 26L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137344: 13H X 26L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137337: 12H X 26L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137320: 11H X 26L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137313: 10H X 26L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137306: 9H X 26L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137290: 8H X 26L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137283: 7H X 26L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137276: 16H X 22L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137269: 15H X 22L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137252: 14H X 22L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137245: 13H X 22L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137238: 12H X 22L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137221: 11H X 22L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137214: 10H X 22L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137207: 9H X 22L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137191: 8H X 22L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137184: 7H X 22L X 12W X 12DEG Impulse Lordotic Trial
• 00842048137177: 16H X 36L X 10W X 12DEG Impulse Lordotic Trial
• 00842048137160: 15H X 36L X 10W X 12DEG Impulse Lordotic Trial
• 00842048137153: 14H X 36L X 10W X 12DEG Impulse Lordotic Trial
• 00842048137146: 13H X 36L X 10W X 12DEG Impulse Lordotic Trial
• 00842048137139: 12H X 36L X 10W X 12DEG Impulse Lordotic Trial
• 00842048137122: 11H X 36L X 10W X 12DEG Impulse Lordotic Trial
• 00842048137115: 10H X 36L X 10W X 12DEG Impulse Lordotic Trial
• 00842048137108: 9H X 36L X 10W X 12DEG Impulse Lordotic Trial
• 00842048137092: 16H X 32L X 10W X 12DEG Impulse Lordotic Trial
• 00842048137085: 15H X 32L X 10W X 12DEG Impulse Lordotic Trial
• 00842048137078: 14H X 32L X 10W X 12DEG Impulse Lordotic Trial