Typenex Medical 097511

GUDID 02816901022564

Weinert Fiber Optics, Inc.

General/multiple surgical diode laser system

• Primary Device ID: 02816901022564
• NIH Device Record Key: 64ca323c-837e-49ac-b7f3-10793f5f9937
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Typenex Medical
• Version Model Number: NV0634
• Catalog Number: 097511
• Company DUNS: 039281260
• Company Name: Weinert Fiber Optics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• 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	00816901022566 [Primary]
GS1	01816901022565 [Package]; Contains: 00816901022566; Package: [5 Units]; In Commercial Distribution
GS1	02816901022564 [Package]; Contains: 01816901022565; Package: [2 Units]; In Commercial Distribution

FDA Product Code

• GEX: Powered laser surgical instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-02
• Device Publish Date: 2021-05-28

On-Brand Devices [Typenex Medical]

• 02816901022564: NV0634
• 02816901023660: NV0632
• 02816901023677: NV0634