FXWIRE FX35450A
GUDID 10653405050506
Advance Measurement Guidewire
Conmed Corporation
General-purpose non-vascular guidewire| Primary Device ID | 10653405050506 |
| NIH Device Record Key | c1261212-cf2e-4248-9775-ced90d5c0c6f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FXWIRE |
| Version Model Number | FX35450A |
| Catalog Number | FX35450A |
| Company DUNS | 071595540 |
| Company Name | Conmed Corporation |
| Device Count | 3 |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
| Outer Diameter | 0.89 Millimeter |
| Length | 450 Centimeter |
| Outer Diameter | 0.035 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00653405050509 [Unit of Use] |
| GS1 | 10653405050506 [Package] Contains: 20653405050503 Package: BOX [3 Units] In Commercial Distribution |
| GS1 | 20653405050503 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K050304
FDA Product Code
| OCY | Endoscopic guidewire, gastroenterology-urology |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
[10653405050506]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [FXWIRE]
| 10653405052906 | Advance Measurement Guidewire |
| 10653405050568 | Advance Measurement Guidewire |
| 10653405050506 | Advance Measurement Guidewire |
| 10653405050469 | Advance Measurement Guidewire |
Trademark Results [FXWIRE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FXWIRE 76606907 3090791 Live/Registered |
CONMED CORPORATION 2004-08-13 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.