LACRIFLOW
GUDID 04540778140868
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| Primary Device ID | 04540778140868 |
| NIH Device Record Key | 257d65a8-23e2-4ce0-a283-b69482c24ba8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LACRIFLOW |
| Version Model Number | LF-R105A |
| 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 | 105 Millimeter |
| Length | 105 Millimeter |
| Length | 105 Millimeter |
| Length | 105 Millimeter |
| Length | 105 Millimeter |
| Length | 105 Millimeter |
| Length | 105 Millimeter |
| Length | 105 Millimeter |
| Length | 105 Millimeter |
| Length | 105 Millimeter |
| Length | 105 Millimeter |
| Length | 105 Millimeter |
| Length | 105 Millimeter |
| Length | 105 Millimeter |
| Length | 105 Millimeter |
| Length | 105 Millimeter |
| Length | 105 Millimeter |
| Length | 105 Millimeter |
| Length | 105 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 | 04540778140868 [Primary] |
| GS1 | 14540778140865 [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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