FEMTO LDVᵀᴹ Intershields 510.710.320

GUDID 07640167750801

Intershield d300 for LCS

SIE AG, Surgical Instrument Engineering

Ophthalmic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 07640167750801
• NIH Device Record Key: 960fd249-283a-4e68-839d-55af0c88bdb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FEMTO LDVᵀᴹ Intershields
• Version Model Number: d300
• Catalog Number: 510.710.320
• Company DUNS: 482163628
• Company Name: SIE AG, Surgical Instrument Engineering
• Device Count: 10
• 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

Customer Support Contacts

• Phone: 8667084490
• Email: usa@ziemergroup.com

Device Dimensions

• Depth: 300 Micrometer

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640167750269 [Unit of Use]
GS1	07640167750801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112154

FDA Product Code

• HQF: Laser, Ophthalmic

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: 2019-11-08
• Device Publish Date: 2016-09-22

On-Brand Devices [FEMTO LDVᵀᴹ Intershields]

• 07640167750856: Intershield d450 for LCS
• 07640167750849: Intershield d420 for LCS
• 07640167750832: Intershield d390 for LCS
• 07640167750825: Intershield d360 for LCS
• 07640167750818: Intershield d330 for LCS
• 07640167750801: Intershield d300 for LCS
• 07640167750795: d200