VisiSheath™ 501-116
GUDID M204501116AA0
VisiSheath™ Dilator Sheath
Spectranetics Corporation
Vascular dilator, single-use| Primary Device ID | M204501116AA0 |
| NIH Device Record Key | 2e475786-e532-4f05-9a89-7e56ea46e07a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VisiSheath™ |
| Version Model Number | 501-116AA |
| Catalog Number | 501-116 |
| 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 | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| complaints@spnc.com | |
| Phone | 1-800-633-0965 |
| 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 | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com |
Device Dimensions
| Lumen/Inner Diameter | 5.9 Millimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
| Lumen/Inner Diameter | 5.9 Millimeter |
| Length | 33 Centimeter |
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 | 00813132020408 [Primary] |
| HIBCC | M204501116AA0 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K092378
FDA Product Code
| DRE | Dilator, Vessel, For Percutaneous Catheterization |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M204501116AA0]
Ethylene Oxide
[M204501116AA0]
Ethylene Oxide
[M204501116AA0]
Ethylene Oxide
[M204501116AA0]
Ethylene Oxide
[M204501116AA0]
Ethylene Oxide
[M204501116AA0]
Ethylene Oxide
[M204501116AA0]
Ethylene Oxide
[M204501116AA0]
Ethylene Oxide
[M204501116AA0]
Ethylene Oxide
[M204501116AA0]
Ethylene Oxide
[M204501116AA0]
Ethylene Oxide
[M204501116AA0]
Ethylene Oxide
[M204501116AA0]
Ethylene Oxide
[M204501116AA0]
Ethylene Oxide
[M204501116AA0]
Ethylene Oxide
[M204501116AA0]
Ethylene Oxide
[M204501116AA0]
Ethylene Oxide
[M204501116AA0]
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 [VisiSheath™]
| M204501216AA0 | VisiSheath™ Dilator Sheath |
| M204501214AA0 | VisiSheath™ Dilator Sheath |
| M204501212AA0 | VisiSheath™ Dilator Sheath |
| M204501116AA0 | VisiSheath™ Dilator Sheath |
| M204501114AA0 | VisiSheath™ Dilator Sheath |
| M204501112AA0 | VisiSheath™ Dilator Sheath |
| M204501016AA0 | VisiSheath™ Dilator Sheath |
| M204501014AA0 | VisiSheath™ Dilator Sheath |
| M204501012AA0 | VisiSheath™ Dilator Sheath |
| M2045012160 | VisiSheath™ Dilator Sheath |
| M2045012140 | VisiSheath™ Dilator Sheath |
| M2045012120 | VisiSheath™ Dilator Sheath |
| M2045011160 | VisiSheath™ Dilator Sheath |
| M2045011140 | VisiSheath™ Dilator Sheath |
| M2045011120 | VisiSheath™ Dilator Sheath |
| M2045010160 | VisiSheath™ Dilator Sheath |
| M2045010140 | VisiSheath™ Dilator Sheath |
| M2045010120 | VisiSheath™ Dilator Sheath |
Trademark Results [VisiSheath]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VISISHEATH 77589213 3768583 Live/Registered |
The Spectranetics Corporation 2008-10-09 |
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