093459

GUDID 01816901020035

FORTEC FIBERS, INC.

Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use

• Primary Device ID: 01816901020035
• NIH Device Record Key: 19dfcaa0-1680-4030-80c7-58641e42b8e4
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SU-200
• Catalog Number: 093459
• 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: 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	00816901020036 [Primary]
GS1	01816901020035 [Package]; Contains: 00816901020036; 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-28

Devices Manufactured by FORTEC FIBERS, INC.

• 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
• 01816901020035 - NA: 2018-07-06
• 01816901020042 - NA: 2018-07-06
• 01816901020059 - NA: 2018-07-06