Guidestar™ Steerable Guiding Sheath D141101
GUDID 00885672009496
Steerable Guiding Sheath, 13.5F
Oscor Inc.
Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use| Primary Device ID | 00885672009496 |
| NIH Device Record Key | 27b13e37-73d8-42dc-95a5-e38eb593d09e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Guidestar™ Steerable Guiding Sheath |
| Version Model Number | D141101 |
| Catalog Number | D141101 |
| Company DUNS | 101835833 |
| Company Name | Oscor 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 |
Customer Support Contacts
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.4 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885672009496 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K140406
FDA Product Code
| DYB | INTRODUCER, CATHETER |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-28 |
| Device Publish Date | 2019-10-19 |
On-Brand Devices [Guidestar™ Steerable Guiding Sheath]
| 00885672009496 | Steerable Guiding Sheath, 13.5F |
| 00885672010911 | Steerable Guiding Sheath, 14F |
| 00885672010904 | Steerable Guiding Sheath, 13.5F |
Trademark Results [Guidestar]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GUIDESTAR 98084978 not registered Live/Pending |
Biosense Webster, Inc. 2023-07-14 |
 GUIDESTAR 97162514 not registered Live/Pending |
Halliburton Energy Services, Inc. 2021-12-08 |
 GUIDESTAR 88022926 not registered Live/Pending |
Biosense Webster, Inc. 2018-07-02 |
 GUIDESTAR 78042727 2776775 Dead/Cancelled |
Athena Technologies Inc. 2001-01-11 |
 GUIDESTAR 77816230 3962552 Live/Registered |
GuideStar Clinical Trials Management, LLC 2009-08-31 |
 GUIDESTAR 77618322 4031979 Dead/Cancelled |
GuideSTAR Technologies, Inc. 2008-11-20 |
 GUIDESTAR 77613556 3816226 Dead/Cancelled |
GuideSTAR Technologies, Inc. 2008-11-13 |
 GUIDESTAR 76422351 2690851 Dead/Cancelled |
Philanthropic Research, Inc. 2002-06-18 |
 GUIDESTAR 76419798 2774849 Dead/Cancelled |
Philanthropic Research, Inc. 2002-06-12 |
 GUIDESTAR 76419797 2882425 Dead/Cancelled |
Philanthropic Research, Inc. 2002-06-12 |
 GUIDESTAR 76419796 2774848 Live/Registered |
THE FOUNDATION CENTER 2002-06-12 |
 GUIDESTAR 76419795 2887114 Live/Registered |
THE FOUNDATION CENTER 2002-06-12 |
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