NGM WAVE I305

GUDID 04251631408666

All instruments provided by NGMedical are reusable surgical instruments with the purpose of enabling the implantation of an NGMedical implant. The surgical technique of each implant describes the instruments to be used. The instruments may only be used in direct connection with implants from NGMedical and as described in the respective surgical techniques.

NGMedical GmbH

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 04251631408666
• NIH Device Record Key: b0b2e77a-1c52-4224-bf1b-ad4b6e1063d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NGM WAVE
• Version Model Number: NGM WAVE Expansion Handle
• Catalog Number: I305
• Company DUNS: 342615118
• Company Name: NGMedical GmbH
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251631408666 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212050

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[04251631408666]

Moist Heat or Steam Sterilization

[04251631408666]

Moist Heat or Steam Sterilization

[04251631408666]

Moist Heat or Steam Sterilization

[04251631408666]

Moist Heat or Steam Sterilization

[04251631408666]

Moist Heat or Steam Sterilization

[04251631408666]

Moist Heat or Steam Sterilization

[04251631408666]

Moist Heat or Steam Sterilization

[04251631408666]

Moist Heat or Steam Sterilization

[04251631408666]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-21
• Device Publish Date: 2022-07-13

On-Brand Devices [NGM WAVE]

• 04251631411079: All instruments provided by NGMedical are reusable surgical instruments with the purpose of enab
• 04251631411062: All instruments provided by NGMedical are reusable surgical instruments with the purpose of enab
• 04251631411055: All instruments provided by NGMedical are reusable surgical instruments with the purpose of enab
• 04251631408680: All instruments provided by NGMedical are reusable surgical instruments with the purpose of enab
• 04251631408673: All instruments provided by NGMedical are reusable surgical instruments with the purpose of enab
• 04251631408666: All instruments provided by NGMedical are reusable surgical instruments with the purpose of enab
• 04251631408659: All instruments provided by NGMedical are reusable surgical instruments with the purpose of enab
• 04251631408642: All instruments provided by NGMedical are reusable surgical instruments with the purpose of enab
• 04251631405566: All instruments provided by NGMedical are reusable surgical instruments with the purpose of enab
• 04251631405559: All instruments provided by NGMedical are reusable surgical instruments with the purpose of enab
• 04251631404644: All instruments provided by NGMedical are reusable surgical instruments with the purpose of enab
• 04251631411123: All instruments provided by NGMedical are reusable surgical instruments with the purpose of enab
• 04251631400110: All instruments provided by NGMedical are reusable surgical instruments with the purpose of enab