Intacs for Keratoconus, Symmetric 0.400 mm 11600-400-150

GUDID 00850048576148

Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.210 to 0.450 mm.

ADDITION TECHNOLOGY, INC.

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• Primary Device ID: 00850048576148
• NIH Device Record Key: 338d9e38-b404-441d-94d4-157c29af58bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intacs for Keratoconus, Symmetric 0.400 mm
• Version Model Number: ICI-400-150
• Catalog Number: 11600-400-150
• 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	00850048576148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H040002

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