| Primary Device ID | M2045180240 |
| NIH Device Record Key | 3600563e-25f5-4383-ac63-6cb46e3d9055 |
| Commercial Distribution Discontinuation | 2019-02-06 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Lead Cutter™ |
| Version Model Number | 518-024 |
| Catalog Number | 518-024 |
| 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 | false |
| 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 |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com | |
| Phone | 1-800-633-0966 |
| complaints@spnc.com |
| 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 |
| 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 |
| 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 Issuing Agency | Device ID |
|---|---|
| HIBCC | M2045180240 [Primary] |
| DRB | Stylet, Catheter |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
[M2045180240]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-10-26 |
| Device Publish Date | 2014-08-19 |
| M204518024AA0 | Lead Cutter™ |
| M2045180240 | Lead Cutter™ |