| Primary Device ID | 00850048576001 |
| NIH Device Record Key | ea955f37-756e-47f9-a3dc-5b3648f3b258 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Intacs Corneal Separator, CW, 0.9mm |
| Version Model Number | KV10730-1 |
| Company DUNS | 118496814 |
| Company Name | ADDITION TECHNOLOGY, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850048576001 [Primary] |
| HND | Spatula, Ophthalmic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850048576001]
Moist Heat or Steam Sterilization
[00850048576001]
Moist Heat or Steam Sterilization
[00850048576001]
Moist Heat or Steam Sterilization
[00850048576001]
Moist Heat or Steam Sterilization
[00850048576001]
Moist Heat or Steam Sterilization
[00850048576001]
Moist Heat or Steam Sterilization
[00850048576001]
Moist Heat or Steam Sterilization
[00850048576001]
Moist Heat or Steam Sterilization
[00850048576001]
Moist Heat or Steam Sterilization
[00850048576001]
Moist Heat or Steam Sterilization
[00850048576001]
Moist Heat or Steam Sterilization
[00850048576001]
Moist Heat or Steam Sterilization
[00850048576001]
Moist Heat or Steam Sterilization
[00850048576001]
Moist Heat or Steam Sterilization
[00850048576001]
Moist Heat or Steam Sterilization
[00850048576001]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-21 |
| Device Publish Date | 2023-06-13 |
| 00850048576001 - Intacs Corneal Separator, CW, 0.9mm | 2023-06-21The Corneal Separators are composed of a stainless-steel tubular body with a 210° blade attached to the body by a spoke. Each Corneal Separator is inserted through the 0.9 mm entry incision to create either a CW or a CCW annular subsurface tunnel. The Corneal Separators are designed for use with the Vacuum Centering Guide (VCG). Each Corneal Separator is designed to slide easily into the VCG and to rotate smoothly through the stroma to precisely create the CW and CCW intrastromal tunnels within the cornea. |
| 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 |