UroWire® Guidewire with SL-6® Hydrophilic Coating Urological Guidewire
GUDID 10607915113831
APPLIED MEDICAL RESOURCES CORPORATION
General-purpose non-vascular guidewire| Primary Device ID | 10607915113831 |
| NIH Device Record Key | d99a4c63-729e-4adf-8be8-1fc184642399 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UroWire® Guidewire with SL-6® Hydrophilic Coating |
| Version Model Number | B8134 |
| Catalog Number | Urological Guidewire |
| Company DUNS | 187129135 |
| Company Name | APPLIED MEDICAL RESOURCES CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1.949.713.8300 |
| contact@appliedmedical.com | |
| Phone | 1.949.713.8300 |
| contact@appliedmedical.com | |
| Phone | 1.949.713.8300 |
| contact@appliedmedical.com |
Device Dimensions
| Outer Diameter | 0.35 Inch |
| Outer Diameter | 0.35 Inch |
| Outer Diameter | 0.35 Inch |
| Outer Diameter | 0.35 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.35 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00607915113834 [Primary] |
| GS1 | 10607915113831 [Package] Contains: 00607915113834 Package: [1 Units] In Commercial Distribution |
FDA Product Code
| KNY | Accessories, Catheter, G-U |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-18 |
On-Brand Devices [UroWire® Guidewire with SL-6® Hydrophilic Coating]
| 10607915113855 | Urological Guidewire |
| 10607915113831 | B8134 |
Trademark Results [UroWire]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 UROWIRE 76478746 2870277 Live/Registered |
APPLIED MEDICAL RESOURCES CORPORATION 2002-12-18 |
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