HI-TORQUE STANDARD 22318H-903
GUDID 28717648079935
HI-TORQUE STANDARD Guide Wire w/Hydrocoat .014 Straight Tip 30 cm x 190 cm
ABBOTT VASCULAR INC.
Cardiac/peripheral vascular guidewire, single-use| Primary Device ID | 28717648079935 |
| NIH Device Record Key | cd9f88a8-67d4-4e2c-9dc0-d9d6e016b40a |
| Commercial Distribution Discontinuation | 2021-01-17 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | HI-TORQUE STANDARD |
| Version Model Number | 22318H-903 |
| Catalog Number | 22318H-903 |
| 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
| Phone | +1(800)227-9902 |
| AV.CUSTOMERCARE@AV.ABBOTT.COM | |
| Phone | +1(800)227-9902 |
| AV.CUSTOMERCARE@AV.ABBOTT.COM | |
| Phone | +1(800)227-9902 |
| AV.CUSTOMERCARE@AV.ABBOTT.COM | |
| Phone | +1(800)227-9902 |
| AV.CUSTOMERCARE@AV.ABBOTT.COM | |
| Phone | +1(800)227-9902 |
| AV.CUSTOMERCARE@AV.ABBOTT.COM | |
| Phone | +1(800)227-9902 |
| AV.CUSTOMERCARE@AV.ABBOTT.COM | |
| Phone | +1(800)227-9902 |
| AV.CUSTOMERCARE@AV.ABBOTT.COM | |
| Phone | +1(800)227-9902 |
| AV.CUSTOMERCARE@AV.ABBOTT.COM | |
| Phone | +1(800)227-9902 |
| AV.CUSTOMERCARE@AV.ABBOTT.COM | |
| Phone | +1(800)227-9902 |
| AV.CUSTOMERCARE@AV.ABBOTT.COM | |
| Phone | +1(800)227-9902 |
| AV.CUSTOMERCARE@AV.ABBOTT.COM | |
| Phone | +1(800)227-9902 |
| AV.CUSTOMERCARE@AV.ABBOTT.COM | |
| Phone | +1(800)227-9902 |
| AV.CUSTOMERCARE@AV.ABBOTT.COM | |
| Phone | +1(800)227-9902 |
| AV.CUSTOMERCARE@AV.ABBOTT.COM | |
| Phone | +1(800)227-9902 |
| AV.CUSTOMERCARE@AV.ABBOTT.COM | |
| Phone | +1(800)227-9902 |
| AV.CUSTOMERCARE@AV.ABBOTT.COM | |
| Phone | +1(800)227-9902 |
| AV.CUSTOMERCARE@AV.ABBOTT.COM |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Stored in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Stored in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Stored in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Stored in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Stored in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Stored in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Stored in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Stored in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Stored in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Stored in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Stored in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Stored in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Stored in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Stored in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Stored in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Stored in a dry, dark, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Stored in a dry, dark, cool place |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08717648079931 [Primary] |
| GS1 | 28717648079935 [Package] Contains: 08717648079931 Package: Case [5 Units] Discontinued: 2021-01-17 Not 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 | 2024-02-07 |
| Device Publish Date | 2016-02-12 |
On-Brand Devices [HI-TORQUE STANDARD]
| 28717648080030 | HI-TORQUE STANDARD Guide Wire .014 Straight Tip 2.0 cm x 300 cm |
| 08717648080029 | HI-TORQUE STANDARD Guide Wire w/Hydrocoat .014 Straight Tip 2.0 cm x 300 cm |
| 28717648079980 | HI-TORQUE STANDARD Guide Wire with MICROGLIDE Coating .014 Straight Tip 2.0 cm x 300 cm |
| 08717648079962 | HI-TORQUESTANDARD Guide Wire .014 Straight Tip 2.0 cm x 190 cm |
| 08717648079955 | HI-TORQUE STANDARD Guide Wire w/Hydrocoat .014 J Tip 30 cm x 190 cm |
| 28717648079942 | HI-TORQUE STANDARD Guide Wire w/Hydrocoat .014 J Tip 2.0 cm x 190 cm |
| 28717648079935 | HI-TORQUE STANDARD Guide Wire w/Hydrocoat .014 Straight Tip 30 cm x 190 cm |
| 28717648079911 | HI-TORQUE STANDARD Guide Wire w/Hydrocoat .014 Straight Tip 2.0 cm x 190 cm |
Trademark Results [HI-TORQUE STANDARD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HI-TORQUE STANDARD 74460110 1879636 Live/Registered |
ABBOTT CARDIOVASCULAR SYSTEMS, INC. 1993-11-18 |
 HI-TORQUE STANDARD 73602554 1453095 Dead/Cancelled |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1986-06-05 |
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