094126

GUDID 01816901021209

FORTEC FIBERS, INC.

Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable

• Primary Device ID: 01816901021209
• NIH Device Record Key: 0350619b-1458-47de-9991-b766849a81c8
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: RE-550-DO
• Catalog Number: 094126
• Company DUNS: 967515367
• Company Name: FORTEC FIBERS, 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: 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	00816901021200 [Primary]
GS1	01816901021209 [Package]; Contains: 00816901021200; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050738

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: 4
• Public Version Date: 2018-11-15
• Device Publish Date: 2016-10-24

Devices Manufactured by FORTEC FIBERS, INC.

• 01816901021209 - NA: 2018-11-15
• 01816901021209 - NA: 2018-11-15
• 01816901021216 - NA: 2018-11-15
• 01816901020004 - NA: 2018-07-06
• 01816901020011 - NA: 2018-07-06
• 01816901020028 - NA: 2018-07-06
• 01816901020035 - NA: 2018-07-06
• 01816901020042 - NA: 2018-07-06
• 01816901020059 - NA: 2018-07-06