Typenex 097594

GUDID 01816901021315

Weinert Fiber Optics, Inc.

Urogenital surgical laser system beam guide, single-use

• Primary Device ID: 01816901021315
• NIH Device Record Key: accdba72-0cc7-4e77-901f-60a6b6733d4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Typenex
• Version Model Number: LF0101X550
• Catalog Number: 097594
• Company DUNS: 039281260
• Company Name: Weinert Fiber Optics, 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: true
• 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	00816901021316 [Primary]
GS1	01816901021315 [Package]; Contains: 00816901021316; Package: [5 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-09
• Device Publish Date: 2023-06-01

On-Brand Devices [Typenex]

• 01816901021384: LF0101X200
• 01816901021315: LF0101X550
• 01816901021308: LF0101X365
• 01816901021292: LF0101X272
• 01816901021339: LF0101X940