| Primary Device ID | 00850048576070 |
| NIH Device Record Key | a2ac067c-b6c3-443a-b653-a4987c9863c7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Intacs Symmetric Glide |
| Version Model Number | KV1160 |
| 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 | 00850048576070 [Primary] |
| HND | Spatula, Ophthalmic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850048576070]
Moist Heat or Steam Sterilization
[00850048576070]
Moist Heat or Steam Sterilization
[00850048576070]
Moist Heat or Steam Sterilization
[00850048576070]
Moist Heat or Steam Sterilization
[00850048576070]
Moist Heat or Steam Sterilization
[00850048576070]
Moist Heat or Steam Sterilization
[00850048576070]
Moist Heat or Steam Sterilization
[00850048576070]
Moist Heat or Steam Sterilization
[00850048576070]
Moist Heat or Steam Sterilization
[00850048576070]
Moist Heat or Steam Sterilization
[00850048576070]
Moist Heat or Steam Sterilization
[00850048576070]
Moist Heat or Steam Sterilization
[00850048576070]
Moist Heat or Steam Sterilization
[00850048576070]
Moist Heat or Steam Sterilization
[00850048576070]
Moist Heat or Steam Sterilization
[00850048576070]
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 | 2023-06-21 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 | 2023-06-21The Symmetric Glide is a bifurcated glide instrument that is manufactured from surgical titanium and is inserted into the 1.2 mm entry incision to effectively guide the CW and CCW Corneal Separators into the stromal pocket. |
| 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 |