Primary Device ID | 14545428038295 |
NIH Device Record Key | 48af4020-b215-4718-8870-41d7a93cf9c4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | RevoWave™ |
Version Model Number | RWUA-3545P |
Catalog Number | RWUA-3545P |
Company DUNS | 693961984 |
Company Name | PIOLAX MEDICAL DEVICES, 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 | 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 |
Length | 450 Centimeter |
Length | 450 Centimeter |
Length | 450 Centimeter |
Length | 450 Centimeter |
Special Storage Condition, Specify | Between 0 and 0 *Avoid exposure to high temperature, high humidity, direct sunlight, ultraviolet light (from germicidal lamp, etc.) and water during storage. |
Special Storage Condition, Specify | Between 0 and 0 *Avoid exposure to high temperature, high humidity, direct sunlight, ultraviolet light (from germicidal lamp, etc.) and water during storage. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04545428038298 [Primary] |
GS1 | 14545428038295 [Package] Contains: 04545428038298 Package: Carton [1 Units] In Commercial Distribution |
OCY | Endoscopic Guidewire, Gastroenterology-Urology |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-04-01 |
Device Publish Date | 2019-03-22 |
14545428038714 | 0.025 Hard |
14545428038707 | 0.025 Hard |
14545428038691 | 0.035 Hard |
14545428038684 | 0.035 Hard |
14545428038646 | 0.025 UltraHard |
14545428038639 | 0.035 Standard |
14545428038370 | 0.025 Hard |
14545428038363 | 0.035 Hard |
14545428038356 | 0.025 Hard |
14545428038349 | 0.025 Hard |
14545428038332 | 0.025 UltraHard |
14545428038325 | 0.035 Standard |
14545428038318 | 0.035 Standard |
14545428038301 | 0.035 Standard |
14545428038295 | 0.035 UltraHard |
14545428038288 | 0.035 Hard |
04545428038274 | 0.035 Hard |
14545428038264 | 0.035 Standard |
14545428038257 | 0.035 Standard |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() REVOWAVE 88248761 not registered Live/Pending |
Kabushiki Kaisha Piolax Medical Device 2019-01-03 |