ZIPwire™ M006630206B0
GUDID 08714729761778
Lake Region Medical
Gastro-urological guidewire, single-use| Primary Device ID | 08714729761778 |
| NIH Device Record Key | 0553093b-32e4-410c-850b-a3ce4fbc1ef7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZIPwire™ |
| Version Model Number | M006630206B0 |
| Catalog Number | M006630206B0 |
| Company DUNS | 031108704 |
| Company Name | Lake Region Medical |
| 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 | true |
| 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 |
Device Dimensions
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08714729761723 [Primary] |
| GS1 | 08714729761778 [Package] Contains: 08714729761723 Package: [5 Units] In Commercial Distribution |
FDA Product Code
| EYA | Stylet, Ureteral |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2024-06-28 |
| Device Publish Date | 2016-10-31 |
On-Brand Devices [ZIPwire™]
Trademark Results [ZIPwire]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZIPWIRE 88186267 not registered Dead/Abandoned |
Skeletal Dynamics Inc. 2018-11-08 |
 ZIPWIRE 86167697 not registered Dead/Abandoned |
Aspect Software, Inc. 2014-01-16 |
 ZIPWIRE 86136559 4993792 Live/Registered |
Zipwire Incorporated 2013-12-05 |
ZIPWIRE 86136559 4993792 Live/Registered |
KAP, LYNETTE ELAYNE 2013-12-05 |
 ZIPWIRE 86122644 5013291 Live/Registered |
Aspect Software, Inc. 2013-11-19 |
 ZIPWIRE 85341385 4207265 Dead/Cancelled |
Revo Brand Group, LLC 2011-06-08 |
 ZIPWIRE 78700441 3277233 Live/Registered |
Boston Scientific Scimed, Inc. 2005-08-25 |
 ZIPWIRE 78027740 2854868 Dead/Cancelled |
MINDSPEED TECHNOLOGIES, INC. 2000-09-26 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.