SightRail™ 550-008
GUDID M204550008AA0
SightRail™ Manual Dilator Sheath
Spectranetics Corporation
Vascular dilator, single-use| Primary Device ID | M204550008AA0 |
| NIH Device Record Key | 09a06393-abcd-461e-866a-be95cb9ed51b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SightRail™ |
| Version Model Number | 550-008AA |
| Catalog Number | 550-008 |
| 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 | |
| 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 | |
| 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 | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com |
Device Dimensions
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 Inch |
| Lumen/Inner Diameter | 0.107 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 |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813132020903 [Primary] |
| HIBCC | M204550008AA0 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133631
FDA Product Code
| DRE | Dilator, Vessel, For Percutaneous Catheterization |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M204550008AA0]
Ethylene Oxide
[M204550008AA0]
Ethylene Oxide
[M204550008AA0]
Ethylene Oxide
[M204550008AA0]
Ethylene Oxide
[M204550008AA0]
Ethylene Oxide
[M204550008AA0]
Ethylene Oxide
[M204550008AA0]
Ethylene Oxide
[M204550008AA0]
Ethylene Oxide
[M204550008AA0]
Ethylene Oxide
[M204550008AA0]
Ethylene Oxide
[M204550008AA0]
Ethylene Oxide
[M204550008AA0]
Ethylene Oxide
[M204550008AA0]
Ethylene Oxide
[M204550008AA0]
Ethylene Oxide
[M204550008AA0]
Ethylene Oxide
[M204550008AA0]
Ethylene Oxide
[M204550008AA0]
Ethylene Oxide
[M204550008AA0]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-02-06 |
On-Brand Devices [SightRail™]
| M204555513AA0 | SightRail™ Manual Dilator Sheath |
| M204555511AA0 | SightRail™ Manual Dilator Sheath |
| M204555510AA0 | SightRail™ Manual Dilator Sheath |
| M204555508AA0 | SightRail™ Manual Dilator Sheath |
| M204550013AA0 | SightRail™ Manual Dilator Sheath |
| M204550011AA0 | SightRail™ Manual Dilator Sheath |
| M204550010AA0 | SightRail™ Manual Dilator Sheath |
| M204550008AA0 | SightRail™ Manual Dilator Sheath |
| M2045555130 | SightRail™ Manual Dilator Sheath |
| M2045555110 | SightRail™ Manual Dilator Sheath |
| M2045555100 | SightRail™ Manual Dilator Sheath |
| M2045555080 | SightRail™ Manual Dilator Sheath |
| M2045500130 | SightRail™ Manual Dilator Sheath |
| M2045500110 | SightRail™ Manual Dilator Sheath |
| M2045500100 | SightRail™ Manual Dilator Sheath |
| M2045500080 | SightRail™ Manual Dilator Sheath |
Trademark Results [SightRail]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIGHTRAIL 86235062 4673064 Live/Registered |
The Spectranetics Corporation 2014-03-28 |
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