TightRail™ 545-513
GUDID M204545513AA0
TightRail™ Rotating Dilator Sheath
Spectranetics Corporation
Vascular dilator, single-use| Primary Device ID | M204545513AA0 |
| NIH Device Record Key | 7877d415-9f89-4eb7-b1e5-cd000bf623ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TightRail™ |
| Version Model Number | 545-513AA |
| Catalog Number | 545-513 |
| 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 | 0.171 Inch |
| Lumen/Inner Diameter | 0.171 Inch |
| Lumen/Inner Diameter | 0.171 Inch |
| Lumen/Inner Diameter | 0.171 Inch |
| Lumen/Inner Diameter | 0.171 Inch |
| Lumen/Inner Diameter | 0.171 Inch |
| Lumen/Inner Diameter | 0.171 Inch |
| Lumen/Inner Diameter | 0.171 Inch |
| Lumen/Inner Diameter | 0.171 Inch |
| Lumen/Inner Diameter | 0.171 Inch |
| Lumen/Inner Diameter | 0.171 Inch |
| Lumen/Inner Diameter | 0.171 Inch |
| Lumen/Inner Diameter | 0.171 Inch |
| Lumen/Inner Diameter | 0.171 Inch |
| Lumen/Inner Diameter | 0.171 Inch |
| Lumen/Inner Diameter | 0.171 Inch |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M204545513AA0 [Primary] |
FDA Product Code
| DRE | Dilator, Vessel, For Percutaneous Catheterization |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M204545513AA0]
Ethylene Oxide
[M204545513AA0]
Ethylene Oxide
[M204545513AA0]
Ethylene Oxide
[M204545513AA0]
Ethylene Oxide
[M204545513AA0]
Ethylene Oxide
[M204545513AA0]
Ethylene Oxide
[M204545513AA0]
Ethylene Oxide
[M204545513AA0]
Ethylene Oxide
[M204545513AA0]
Ethylene Oxide
[M204545513AA0]
Ethylene Oxide
[M204545513AA0]
Ethylene Oxide
[M204545513AA0]
Ethylene Oxide
[M204545513AA0]
Ethylene Oxide
[M204545513AA0]
Ethylene Oxide
[M204545513AA0]
Ethylene Oxide
[M204545513AA0]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2021-10-26 |
| Device Publish Date | 2015-03-12 |
On-Brand Devices [TightRail™]
| 00813132021658 | TightRail™ Rotating Dilator Sheath |
| 00813132021641 | TightRail™ Rotating Dilator Sheath |
| 00813132021634 | TightRail™ Rotating Dilator Sheath |
| M204545513AB0 | TightRail™ Rotating Dilator Sheath |
| M204545511AB0 | TightRail™ Rotating Dilator Sheath |
| M204545509AB0 | TightRail™ Rotating Dilator Sheath |
| M204545513AA0 | TightRail™ Rotating Dilator Sheath |
| M2045455130 | TightRail™ Rotating Dilator Sheath |
| M204545511AA0 | TightRail™ Rotating Dilator Sheath |
| M2045455110 | TightRail™ Rotating Dilator Sheath |
| M204545509AA0 | TightRail™ Rotating Dilator Sheath |
| M2045455090 | TightRail™ Rotating Dilator Sheath |
Trademark Results [TightRail]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TIGHTRAIL 86235144 4673065 Live/Registered |
The Spectranetics Corporation 2014-03-28 |
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