LACRIFLOW
GUDID 04540778140875
The LACRIFLOW is indicated in treatments of epiphora in-patients 12 months and older, in cases of: - Canalicular pathologies (stenosis, obstruction, lacerations), - During Dacryocystorhinostomy (conventional or laser), - Congenital nasolacrimal duct obstruction.
KANEKA CORPORATION
Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube Lacrimal tube| Primary Device ID | 04540778140875 |
| NIH Device Record Key | 6834f182-0142-422d-ab8d-5c67edd6da20 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LACRIFLOW |
| Version Model Number | LF-R090A |
| Company DUNS | 690535406 |
| Company Name | KANEKA CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-800-526-3521 |
| takuji.hasegawa@kaneka.com | |
| Phone | 1-800-526-3521 |
| takuji.hasegawa@kaneka.com | |
| Phone | 1-800-526-3521 |
| takuji.hasegawa@kaneka.com | |
| Phone | 1-800-526-3521 |
| takuji.hasegawa@kaneka.com | |
| Phone | 1-800-526-3521 |
| takuji.hasegawa@kaneka.com | |
| Phone | 1-800-526-3521 |
| takuji.hasegawa@kaneka.com | |
| Phone | 1-800-526-3521 |
| takuji.hasegawa@kaneka.com | |
| Phone | 1-800-526-3521 |
| takuji.hasegawa@kaneka.com | |
| Phone | 1-800-526-3521 |
| takuji.hasegawa@kaneka.com | |
| Phone | 1-800-526-3521 |
| takuji.hasegawa@kaneka.com | |
| Phone | 1-800-526-3521 |
| takuji.hasegawa@kaneka.com | |
| Phone | 1-800-526-3521 |
| takuji.hasegawa@kaneka.com | |
| Phone | 1-800-526-3521 |
| takuji.hasegawa@kaneka.com | |
| Phone | 1-800-526-3521 |
| takuji.hasegawa@kaneka.com | |
| Phone | 1-800-526-3521 |
| takuji.hasegawa@kaneka.com | |
| Phone | 1-800-526-3521 |
| takuji.hasegawa@kaneka.com | |
| Phone | 1-800-526-3521 |
| takuji.hasegawa@kaneka.com | |
| Phone | 1-800-526-3521 |
| takuji.hasegawa@kaneka.com | |
| Phone | 1-800-526-3521 |
| takuji.hasegawa@kaneka.com |
Device Dimensions
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
| Length | 90 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the LACRIFLOW in the place avoiding direct sunlight at room temperature. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04540778140875 [Primary] |
| GS1 | 14540778140872 [Package] Package: [2 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K120886
FDA Product Code
| OKS | Lacrimal Stents And Intubation Sets |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2016-09-17 |
On-Brand Devices [LACRIFLOW]
| 04540778140875 | The LACRIFLOW is indicated in treatments of epiphora in-patients 12 months and older, in cases o |
| 04540778140868 | The LACRIFLOW is indicated in treatments of epiphora in-patients 12 months and older, in cases o |
Trademark Results [LACRIFLOW]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LACRIFLOW 86868579 5075091 Live/Registered |
KANEKA CORPORATION 2016-01-07 |
 LACRIFLOW 85798618 4437541 Live/Registered |
KANEKA CORPORATION 2012-12-10 |
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