Guidewire SGW-019-38
GUDID 20841268100859
Guidewire
GALT MEDICAL CORP.
Peripheral vascular guidewire, manual| Primary Device ID | 20841268100859 |
| NIH Device Record Key | cdf3410f-2bbc-40ee-980e-9f3927515128 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Guidewire |
| Version Model Number | SGW-019-38 |
| Catalog Number | SGW-019-38 |
| 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
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 |
| 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 | 00841268100855 [Primary] |
| GS1 | 10841268100852 [Package] Contains: 00841268100855 Package: Shelf Box [10 Units] In Commercial Distribution |
| GS1 | 20841268100859 [Package] Contains: 10841268100852 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 |
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
[20841268100859]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-07-03 |
On-Brand Devices [Guidewire]
Trademark Results [Guidewire]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GUIDEWIRE 87540652 5401314 Live/Registered |
Guidewire Software, Inc. 2017-07-24 |
 GUIDEWIRE 78662211 3185991 Live/Registered |
Guidewire Software, Inc. 2005-06-30 |
 GUIDEWIRE 77016329 3273576 Dead/Cancelled |
Yu, Steven S. 2006-10-07 |
 GUIDEWIRE 76474094 not registered Dead/Abandoned |
GUIDEWIRE SYSTEMS, INC. 2002-12-12 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.