FiberLase

GUDID 00860009714915

FiberLase GYN LAP-R Handpiece

TRANSAMERICAN TECHNOLOGIES INTERNATIONAL

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 00860009714915
• NIH Device Record Key: 9212817f-dfbe-41ab-9fbe-c216f57493b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FiberLase
• Version Model Number: AC-1059620
• Company DUNS: 130213366
• Company Name: TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009714915 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K952006

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

[00860009714915]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2023-05-09
• Device Publish Date: 2016-06-20

On-Brand Devices [FiberLase]

• 00860009714946: SS FiberLase GYN LAP-S Handpiece
• 00860009714939: SS FiberLase GYN LAP-R Handpiece
• 00860009714922: Cleaning Kit for FiberLase GYN Lap Handpieces
• 00860009714915: FiberLase GYN LAP-R Handpiece
• 00860009714908: FiberLase GYN LAP-S Handpiece