Posi-Stick® Guidewire PS2-18
GUDID 20841268108404
Posi-Stick® Guidewire
GALT MEDICAL CORP.
Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual 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.
| 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 |
| 10841268109879 - 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.