SafeSept® Transseptal Guidewire SS-135
GUDID 00891492002395
Transseptal Guidewire
Oscor Inc.
Cardiac transseptal needle, single-use| Primary Device ID | 00891492002395 |
| NIH Device Record Key | b8e54144-c340-4c83-a00d-5de8b9f0b1a8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SafeSept® Transseptal Guidewire |
| Version Model Number | SS-135 |
| Catalog Number | SS-135 |
| 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 |
Device Dimensions
| Length | 135 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 135 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 135 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 135 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 135 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 135 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 135 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 135 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 135 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 135 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 135 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 135 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 135 Centimeter |
| Outer Diameter | 0.014 Inch |
| Length | 135 Centimeter |
| Outer Diameter | 0.014 Inch |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00891492002395 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K081986
FDA Product Code
| DRC | Trocar |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-08-20 |
| Device Publish Date | 2017-11-27 |
Devices Manufactured by Oscor Inc.
| 00885672012694 - SafeSheath® II | 2024-11-05 Hemostatic Tear-away Introducer, 9F |
| 00885672012632 - SafeSheath® II | 2024-07-25 Hemostatic Tear-away Introducer System with Infusion Side Port, 9F, 30 cm |
| 00885672012649 - SafeSheath® II | 2024-07-25 Hemostatic Tear-away Introducer System with Infusion Side Port, 9F, 40 cm |
| 00885672101466 - Guidewire | 2023-09-15 Guidewire with PTFE coating |
| 10885672102576 - ATAR D-R X2L | 2023-09-08 Disposable Extension Cable |
| 00885672012489 - Baylis Med Tech Passport Steerable Sheath | 2023-03-23 Passport Steerable Sheath 6.5F |
| 00885672012496 - Baylis Med Tech Passport Steerable Sheath | 2023-03-23 Passport Steerable Sheath 6.5F |
| 00885672012502 - Baylis Med Tech Passport Steerable Sheath | 2023-03-23 Passport Steerable Sheath 6.5F |
Trademark Results [SafeSept]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SAFESEPT 87249371 5232606 Live/Registered |
Pressure Products Medical Supplies Inc. 2016-11-28 |
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