Single use surgical optical fiber

GUDID 08051272101195

550um surgical optical fiber

HYPER PHOTONICS SRL

General/multiple surgical laser system beam guide, single-use

• Primary Device ID: 08051272101195
• NIH Device Record Key: 3ecfb422-0af7-49d0-a753-688795c32d4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single use surgical optical fiber
• Version Model Number: BO000017
• Company DUNS: 430142152
• Company Name: HYPER PHOTONICS SRL
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08051272101188 [Primary]
GS1	08051272101195 [Package]; Contains: 08051272101188; Package: carton box [5 Units]; In Commercial Distribution
GS1	08051272101201 [Package]; Package: carton box [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163449

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: 5
• Public Version Date: 2021-04-07
• Device Publish Date: 2018-02-16

On-Brand Devices [Single use surgical optical fiber]

• 08051272101263: 272um surgical optical fiber
• 08051272101195: 550um surgical optical fiber
• 08051272101140: 365um surgical optical fiber
• 08051272101089: 200um surgical optical fiber