DiRex™ Steerable Sheath M004DIREX350
GUDID 00885672009335
Steerable sheath, 8.5F
Oscor Inc.
Vascular guide-catheter, single-use| Primary Device ID | 00885672009335 |
| NIH Device Record Key | 69b6d3c4-6f81-48fc-b010-16bd223258ca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DiRex™ Steerable Sheath |
| Version Model Number | M004DIREX350 |
| Catalog Number | M004DIREX350 |
| 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 |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.8 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.8 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.8 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.8 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.8 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.8 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.8 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.8 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.8 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.8 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.8 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.8 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.8 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2.8 Millimeter |
| Device Size Text, specify | 0 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885672009335 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K120459
FDA Product Code
| DYB | INTRODUCER, CATHETER |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-11-20 |
| Device Publish Date | 2019-05-01 |
On-Brand Devices [DiRex™ Steerable Sheath]
| 00885672009373 | Steerable sheath, 12F |
| 00885672009366 | Steerable sheath, 12F |
| 00885672009359 | Steerable sheath, 10F |
| 00885672009342 | Steerable sheath, 10F |
| 00885672009335 | Steerable sheath, 8.5F |
| 00885672009328 | Steerable sheath, 8.5F |
| 00885672009311 | Steerable sheath, 8.5F |
| 00885672009304 | Steerable sheath, 8.5F |
| 00885672009298 | Steerable sheath, 8.5F |
| 00885672009281 | Steerable sheath, 8.5F |
| 08714729858997 | Steerable sheath, 12F |
| 08714729858980 | Steerable sheath, 12F |
| 08714729858973 | Steerable sheath, 10F |
| 08714729858966 | Steerable sheath, 10F |
| 08714729858959 | Steerable sheath, 8.5F |
| 08714729858942 | Steerable sheath, 8.5F |
| 08714729858935 | Steerable sheath, 8.5F |
| 08714729858928 | Steerable sheath, 8.5F |
| 08714729858911 | Steerable sheath, 8.5F |
| 08714729858904 | Steerable sheath, 8.5F |
Trademark Results [DiRex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIREX 85607659 4355242 Live/Registered |
BOSTON SCIENTIFIC SCIMED, INC. 2012-04-25 |
 DIREX 79362192 not registered Live/Pending |
Wacker Neuson Produktion GmbH & Co. KG 2022-12-22 |
 DIREX 78586104 not registered Dead/Abandoned |
Bradley W. Miller 2005-03-13 |
 DIREX 78192609 not registered Dead/Abandoned |
DIREX INC. 2002-12-09 |
 DIREX 77965070 not registered Dead/Abandoned |
Smart Business Technology 2010-03-22 |
 DIREX 77115689 not registered Dead/Abandoned |
Quantum Medical Imaging, LLC 2007-02-25 |
 DIREX 75320094 not registered Dead/Abandoned |
Truvativ International Co., Ltd. 1997-07-07 |
 DIREX 74148672 1676536 Live/Registered |
ADAMA AGAN LTD. 1991-03-18 |
 DIREX 73765329 not registered Dead/Abandoned |
NIXDORF COMPUTER AG 1988-11-18 |
 DIREX 73477708 1368710 Dead/Cancelled |
INTRAK, INC. 1984-04-27 |
 DIREX 72275090 0865700 Dead/Expired |
VICTORY DIAMOND TOOL COMPANY 1967-06-29 |
 DIREX 71489864 0421563 Dead/Expired |
GRANT PHOTO PRODUCTS, INC. 1945-10-12 |
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