| Primary Device ID | 00850048576032 |
| NIH Device Record Key | 63f63547-6516-482e-97e8-901eed552594 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Intacs Procedure Marker |
| Version Model Number | KV10733 |
| 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 | 00850048576032 [Primary] |
| HMR | Marker, Ocular |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850048576032]
Moist Heat or Steam Sterilization
[00850048576032]
Moist Heat or Steam Sterilization
[00850048576032]
Moist Heat or Steam Sterilization
[00850048576032]
Moist Heat or Steam Sterilization
[00850048576032]
Moist Heat or Steam Sterilization
[00850048576032]
Moist Heat or Steam Sterilization
[00850048576032]
Moist Heat or Steam Sterilization
[00850048576032]
Moist Heat or Steam Sterilization
[00850048576032]
Moist Heat or Steam Sterilization
[00850048576032]
Moist Heat or Steam Sterilization
[00850048576032]
Moist Heat or Steam Sterilization
[00850048576032]
Moist Heat or Steam Sterilization
[00850048576032]
Moist Heat or Steam Sterilization
[00850048576032]
Moist Heat or Steam Sterilization
[00850048576032]
Moist Heat or Steam Sterilization
[00850048576032]
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 | 2023-06-21 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 | 2023-06-21The Procedure Marker, 0.9 mm is used for marking the 1.2 mm incision and the placement marks for the 150 degree Intacs® Corneal Implants by aligning the reticle with the center mark that has been created on the cornea. This multi-functional device is also used later in the surgical procedure to align the Vacuum Centering Guide on the cornea. |
| 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 |