HI-TORQUE FLOPPY 22339H
GUDID 28717648080047
HI-TORQUE FLOPPY II Guide Wire w/Hydrocoat .014 Straight Tip 2.0 cm x 190 cm
ABBOTT VASCULAR INC.
Cardiac/peripheral vascular guidewire, single-use| Primary Device ID | 28717648080047 |
| NIH Device Record Key | c1435111-7bef-4595-a165-2c836a9e7eb3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HI-TORQUE FLOPPY |
| Version Model Number | 22339H |
| Catalog Number | 22339H |
| Company DUNS | 964569052 |
| Company Name | ABBOTT VASCULAR INC. |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 190 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 190 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 190 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 190 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 190 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 190 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 190 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 190 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 190 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 190 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 190 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 190 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 190 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 190 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 190 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 190 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Guidewire Length | 190 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08717648080043 [Primary] |
| GS1 | 28717648080047 [Package] Contains: 08717648080043 Package: Case [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K974773
FDA Product Code
| DQX | WIRE, GUIDE, CATHETER |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-03-23 |
| Device Publish Date | 2016-02-12 |
On-Brand Devices [HI-TORQUE FLOPPY]
| 08717648080357 | HI-TORQUE FLOPPY II Guide Wire .014 J Tip 2.0 cm x 300 cm |
| 08717648080326 | HI-TORQUE FLOPPY II EXTRA SUPPORT GuideWire .014 Straight Tip 2.0 cm x 300 cm |
| 08717648080319 | HI-TORQUE FLOPPY II Guide Wire .014 Straight Tip 2.0 cm x 300 cm |
| 08717648080135 | HI-TORQUE FLOPPY II Guide Wire .014 J Tip 2.0 cm x 190 cm |
| 28717648080122 | HI-TORQUE FLOPPY II Guide Wire .014Straight Tip 30 cm x 190 cm |
| 08717648080111 | HI-TORQUE FLOPPY II Guide Wire .014 Straight Tip 2.0 cm x 50 cm |
| 28717648080092 | HI-TORQUE FLOPPY II Guide Wire .014 Straight Tip 2.0 cm x 190 cm |
| 28717648080047 | HI-TORQUE FLOPPY II Guide Wire w/Hydrocoat .014 Straight Tip 2.0 cm x 190 cm |
| 28717648079706 | HI-TORQUE FLOPPY II EXTRA SUPPORT GuideWire .014 Straight Tip 30 cm x 190 cm |
| 28717648079690 | HI-TORQUE FLOPPY II EXTRA SUPPORT GuideWire .014 Straight Tip 2.0 cm x 190 cm |
| 28717648079652 | HI-TORQUE FLOPPY II Extra Support Guide Wire with HYDROCOAT Hydrophilic Coating .014 Straight Ti |
| 28717648079560 | HI-TORQUE FLOPPY Guide Wire .018 Straight 2.0 cm Tip / 50 cm |
Trademark Results [HI-TORQUE FLOPPY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HI-TORQUE FLOPPY 74290057 1800621 Live/Registered |
ABBOTT CARDIOVASCULAR SYSTEMS, INC. 1992-06-30 |
 HI-TORQUE FLOPPY 73584437 1440319 Live/Registered |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1986-02-24 |
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