Posi-Stick® Guidewire PS2-18
GUDID 20841268108404
Posi-Stick® Guidewire
GALT MEDICAL CORP.
Peripheral vascular guidewire, manual| Primary Device ID | 20841268108404 |
| NIH Device Record Key | d9c79adf-f397-4990-9a8b-91610bd15ff4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Posi-Stick® Guidewire |
| Version Model Number | SGW-068-00 |
| Catalog Number | PS2-18 |
| Company DUNS | 943156836 |
| Company Name | GALT MEDICAL CORP. |
| 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 | true |
| 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 | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com |
Device Dimensions
| Outer Diameter | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841268108400 [Primary] |
| GS1 | 10841268108407 [Package] Contains: 00841268108400 Package: Shelf box [10 Units] In Commercial Distribution |
| GS1 | 20841268108404 [Package] Contains: 10841268108407 Package: Shipper Box [50 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K021990
FDA Product Code
| DQX | Wire, Guide, Catheter |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20841268108404]
Ethylene Oxide
[20841268108404]
Ethylene Oxide
[20841268108404]
Ethylene Oxide
[20841268108404]
Ethylene Oxide
[20841268108404]
Ethylene Oxide
[20841268108404]
Ethylene Oxide
[20841268108404]
Ethylene Oxide
[20841268108404]
Ethylene Oxide
[20841268108404]
Ethylene Oxide
[20841268108404]
Ethylene Oxide
[20841268108404]
Ethylene Oxide
[20841268108404]
Ethylene Oxide
[20841268108404]
Ethylene Oxide
[20841268108404]
Ethylene Oxide
[20841268108404]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-02-18 |
| Device Publish Date | 2019-01-18 |
Devices Manufactured by GALT MEDICAL CORP.
| 10841268110134 - Guidewire | 2024-08-09 Guidewire |
| 10841268109800 - Elite Transitionless Micro-Introducer Kit | 2022-08-23 Elite Transitionless Micro-Introducer Kit |
| 10841268109817 - Elite Transitionless Micro-Introducer Kit | 2022-08-23 Elite Transitionless Micro-Introducer Kit |
| 10841268109824 - Elite Transitionless Micro-Introducer Kit | 2022-08-23 Elite Transitionless Micro-Introducer Kit |
| 10841268109831 - Elite Transitionless Micro-Introducer Kit | 2022-08-23 Elite Transitionless Micro-Introducer Kit |
| 10841268109848 - Elite Transitionless Micro-Introducer Kit | 2022-08-23 Elite Transitionless Micro-Introducer Kit |
| 10841268109855 - Elite Transitionless Micro-Introducer Kit | 2022-08-23 Elite Transitionless Micro-Introducer Kit |
| 10841268109862 - Elite Transitionless Micro-Introducer Kit | 2022-08-23 Elite Transitionless Micro-Introducer Kit |
Trademark Results [Posi-Stick]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POSI-STICK 75089045 2072875 Live/Registered |
URESIL, LLC 1996-04-16 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.