TightRail Mini™ 540-009
GUDID M2045400090
TightRail Mini™ Rotating Dilator Sheath
Spectranetics Corporation
Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use| Primary Device ID | M2045400090 |
| NIH Device Record Key | d52b1222-dae0-47e8-9bed-74f737b6a1ec |
| Commercial Distribution Discontinuation | 2019-02-06 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | TightRail Mini™ |
| Version Model Number | 540-009 |
| Catalog Number | 540-009 |
| Company DUNS | 151047370 |
| Company Name | Spectranetics Corporation |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com |
Device Dimensions
| Lumen/Inner Diameter | 0.119 Inch |
| Lumen/Inner Diameter | 0.119 Inch |
| Lumen/Inner Diameter | 0.119 Inch |
| Lumen/Inner Diameter | 0.119 Inch |
| Lumen/Inner Diameter | 0.119 Inch |
| Lumen/Inner Diameter | 0.119 Inch |
| Lumen/Inner Diameter | 0.119 Inch |
| Lumen/Inner Diameter | 0.119 Inch |
| Lumen/Inner Diameter | 0.119 Inch |
| Lumen/Inner Diameter | 0.119 Inch |
| Lumen/Inner Diameter | 0.119 Inch |
| Lumen/Inner Diameter | 0.119 Inch |
| Lumen/Inner Diameter | 0.119 Inch |
| Lumen/Inner Diameter | 0.119 Inch |
| Lumen/Inner Diameter | 0.119 Inch |
| Lumen/Inner Diameter | 0.119 Inch |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M2045400090 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141131
FDA Product Code
| DRE | Dilator, Vessel, For Percutaneous Catheterization |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M2045400090]
Ethylene Oxide
[M2045400090]
Ethylene Oxide
[M2045400090]
Ethylene Oxide
[M2045400090]
Ethylene Oxide
[M2045400090]
Ethylene Oxide
[M2045400090]
Ethylene Oxide
[M2045400090]
Ethylene Oxide
[M2045400090]
Ethylene Oxide
[M2045400090]
Ethylene Oxide
[M2045400090]
Ethylene Oxide
[M2045400090]
Ethylene Oxide
[M2045400090]
Ethylene Oxide
[M2045400090]
Ethylene Oxide
[M2045400090]
Ethylene Oxide
[M2045400090]
Ethylene Oxide
[M2045400090]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-10-26 |
| Device Publish Date | 2014-08-26 |
On-Brand Devices [TightRail Mini™]
| 00813132021627 | TightRail Mini™ Rotating Dilator Sheath |
| 00813132021610 | TightRail Mini™ Rotating Dilator Sheath |
| M204540011AB0 | TightRail Mini™ Rotating Dilator Sheath |
| M204540009AB0 | TightRail Mini™ Rotating Dilator Sheath |
| M204540011AA0 | TightRail Mini™ Rotating Dilator Sheath |
| M2045400110 | TightRail Mini™ Rotating Dilator Sheath |
| M204540009AA0 | TightRail Mini™ Rotating Dilator Sheath |
| M2045400090 | TightRail Mini™ Rotating Dilator Sheath |
Trademark Results [TightRail Mini]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TIGHTRAIL MINI 86235187 4729002 Live/Registered |
The Spectranetics Corporation 2014-03-28 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.