Intacs for Keratoconus, Symmetric 0.450 mm 11600-450-150

GUDID 00850048576155

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.

Intracorneal ring segment
Primary Device ID00850048576155
NIH Device Record Key692e596c-4cd7-4ecb-9cdb-6de3ef92629d
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntacs for Keratoconus, Symmetric 0.450 mm
Version Model NumberICI-450-150
Catalog Number11600-450-150
Company DUNS118496814
Company NameADDITION TECHNOLOGY, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850048576155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LQEImplant, Corneal, Refractive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-21
Device Publish Date2023-06-13

Devices Manufactured by ADDITION TECHNOLOGY, INC.

00850048576001 - Intacs Corneal Separator, CW, 0.9mm2023-06-21 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, 0.9mm2023-06-21 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 Gauge2023-06-21 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 Marker2023-06-21 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 Forceps2023-06-21 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 Guide2023-06-21 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 Hook2023-06-21 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 Glide2023-06-21 The Symmetric Glide is a bifurcated glide instrument that is manufactured from surgical titanium and is inserted into the 1.2 mm

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