Intacs for Myopia, Symmetric 0.350 mm 11700-350-150

GUDID 00850048576216

Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the correction of myopia without interfering with the patient’s central visual axis. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.250 to 0.350 mm.

ADDITION TECHNOLOGY, INC.

Intracorneal ring segment

• Primary Device ID: 00850048576216
• NIH Device Record Key: 0262c7b1-9023-4460-bec8-80b8feac8499
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intacs for Myopia, Symmetric 0.350 mm
• Version Model Number: ICI-350-150
• Catalog Number: 11700-350-150
• Company DUNS: 118496814
• Company Name: ADDITION TECHNOLOGY, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850048576216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P980031

FDA Product Code

• LQE: Implant, Corneal, Refractive

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-21
• Device Publish Date: 2023-06-13

Devices Manufactured by ADDITION TECHNOLOGY, INC.

• 00850048576001 - Intacs Corneal Separator, CW, 0.9mm: 2023-06-21 The Corneal Separators are composed of a stainless-steel tubular body with a 210° blade attached to the body by a spoke. Each
• 00850048576018 - Intacs Corneal Separator, CCW, 0.9mm: 2023-06-21 The Corneal Separators are composed of a stainless-steel tubular body with a 210° blade attached to the body by a spoke. Each
• 00850048576025 - Intacs Inspection Gauge: 2023-06-21 The Inspection Gauge, 0.9 mm is used as a reference to inspect the concentricity and planarity of the 0.9 mm CW and CCW Corneal
• 00850048576032 - Intacs Procedure Marker: 2023-06-21 The Procedure Marker, 0.9 mm is used for marking the 1.2 mm incision and the placement marks for the 150 degree Intacs® Corneal
• 00850048576049 - Intacs Forceps: 2023-06-21 Designed to be used in an operating room environment by a surgeon to secure hold and facilitate placement of the INTACS implant.
• 00850048576056 - Intacs Vacuum Centering Guide: 2023-06-21 The Vacuum Centering Guide (VCG) is composed of stainless steel and features a port for attachment to a vacuum source (KV2000 Va
• 00850048576063 - Intacs Pocketing Hook: 2023-06-21 Designed to be used in an operating room environment by a surgeon to delaminate cornea stroma to initiate a pocket on each side
• 00850048576070 - Intacs Symmetric Glide: 2023-06-21 The Symmetric Glide is a bifurcated glide instrument that is manufactured from surgical titanium and is inserted into the 1.2 mm