Primary Device ID | 00733132657902 |
NIH Device Record Key | 5a74949e-5e13-466e-b641-2a7f221d297a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GORE TIPS Set |
Version Model Number | TSET1016 |
Catalog Number | TSET1016 |
Company DUNS | 967358115 |
Company Name | W. L. Gore & Associates, 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 | true |
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 |
Phone | 800-528-8763 |
mpdcustomercare@wlgore.com | |
Phone | 800-528-8763 |
mpdcustomercare@wlgore.com | |
Phone | 800-528-8763 |
mpdcustomercare@wlgore.com | |
Phone | 800-528-8763 |
mpdcustomercare@wlgore.com | |
Phone | 800-528-8763 |
mpdcustomercare@wlgore.com | |
Phone | 800-528-8763 |
mpdcustomercare@wlgore.com | |
Phone | 800-528-8763 |
mpdcustomercare@wlgore.com | |
Phone | 800-528-8763 |
mpdcustomercare@wlgore.com | |
Phone | 800-528-8763 |
mpdcustomercare@wlgore.com | |
Phone | 800-528-8763 |
mpdcustomercare@wlgore.com | |
Phone | 800-528-8763 |
mpdcustomercare@wlgore.com | |
Phone | 800-528-8763 |
mpdcustomercare@wlgore.com | |
Phone | 800-528-8763 |
mpdcustomercare@wlgore.com | |
Phone | 800-528-8763 |
mpdcustomercare@wlgore.com | |
Phone | 800-528-8763 |
mpdcustomercare@wlgore.com | |
Phone | 800-528-8763 |
mpdcustomercare@wlgore.com | |
Phone | 800-528-8763 |
mpdcustomercare@wlgore.com |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Catheter Gauge | 10 French |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00733132657902 [Primary] |
DYB | Introducer, Catheter |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-07-23 |
Device Publish Date | 2024-07-15 |
00733132658855 - GORE® DrySeal Flex Introducer Sheath | 2024-12-10 DrySeal Hydro Flex Sheath PI 33cmx10Fr |
00733132658862 - GORE® DrySeal Flex Introducer Sheath | 2024-12-10 DrySeal Hydro Flex Sheath PI 45cmx10Fr |
00733132658879 - GORE® DrySeal Flex Introducer Sheath | 2024-12-10 DrySeal Hydro Flex Sheath PI 65cmx10Fr |
00733132658886 - GORE® DrySeal Flex Introducer Sheath | 2024-12-10 DrySeal Hydro Flex Sheath PI 33cmx11Fr |
00733132658893 - GORE® DrySeal Flex Introducer Sheath | 2024-12-10 DrySeal Hydro Flex Sheath Ao 33cmx12Fr |
00733132658909 - GORE® DrySeal Flex Introducer Sheath | 2024-12-10 DrySeal Hydro Flex Sheath Ao 45cmx12Fr |
00733132658916 - GORE® DrySeal Flex Introducer Sheath | 2024-12-10 DrySeal Hydro Flex Sheath IC 65cmx12Fr |
00733132658923 - GORE® DrySeal Flex Introducer Sheath | 2024-12-10 DrySeal Hydro Flex Sheath Ao 33cmx14Fr |