LLD EZ™ 518-062
GUDID M204518062AA0
Lead Locking Device (LLD™ EZ)
Spectranetics Corporation
Pacing/defibrillation lead stylet, extraction| Primary Device ID | M204518062AA0 |
| NIH Device Record Key | 97e242b5-a5c0-45e6-bd6d-7e562d66f403 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LLD EZ™ |
| Version Model Number | 518-062AA |
| Catalog Number | 518-062 |
| 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 |
Customer Support Contacts
| Phone | 1-800-633-0970 |
| complaints@spnc.com | |
| Phone | 1-800-633-0970 |
| complaints@spnc.com | |
| Phone | 1-800-633-0970 |
| complaints@spnc.com | |
| Phone | 1-800-633-0970 |
| complaints@spnc.com | |
| Phone | 1-800-633-0970 |
| complaints@spnc.com | |
| Phone | 1-800-633-0970 |
| complaints@spnc.com | |
| Phone | 1-800-633-0970 |
| complaints@spnc.com | |
| Phone | 1-800-633-0970 |
| complaints@spnc.com | |
| Phone | 1-800-633-0970 |
| complaints@spnc.com | |
| Phone | 1-800-633-0970 |
| complaints@spnc.com | |
| Phone | 1-800-633-0970 |
| complaints@spnc.com | |
| Phone | 1-800-633-0970 |
| complaints@spnc.com | |
| Phone | 1-800-633-0970 |
| complaints@spnc.com | |
| Phone | 1-800-633-0970 |
| complaints@spnc.com | |
| Phone | 1-800-633-0970 |
| complaints@spnc.com | |
| Phone | 1-800-633-0970 |
| complaints@spnc.com | |
| Phone | 1-800-633-0970 |
| complaints@spnc.com | |
| Phone | 1-800-633-0970 |
| complaints@spnc.com |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813132020842 [Primary] |
| GS1 | 20813132020846 [Package] Contains: 00813132020842 Package: Box [3 Units] In Commercial Distribution |
| HIBCC | M204518062AA0 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142116
FDA Product Code
| DRB | Stylet, Catheter |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M204518062AA0]
Ethylene Oxide
[M204518062AA0]
Ethylene Oxide
[M204518062AA0]
Ethylene Oxide
[M204518062AA0]
Ethylene Oxide
[M204518062AA0]
Ethylene Oxide
[M204518062AA0]
Ethylene Oxide
[M204518062AA0]
Ethylene Oxide
[M204518062AA0]
Ethylene Oxide
[M204518062AA0]
Ethylene Oxide
[M204518062AA0]
Ethylene Oxide
[M204518062AA0]
Ethylene Oxide
[M204518062AA0]
Ethylene Oxide
[M204518062AA0]
Ethylene Oxide
[M204518062AA0]
Ethylene Oxide
[M204518062AA0]
Ethylene Oxide
[M204518062AA0]
Ethylene Oxide
[M204518062AA0]
Ethylene Oxide
[M204518062AA0]
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 [LLD EZ™]
| 20813132023076 | Lead Locking Device (LLD™ EZ) |
| M204518067AB0 | Lead Locking Device (LLD™ EZ) |
| M204518062AA0 | Lead Locking Device (LLD™ EZ) |
| 00813132020835 | Lead Locking Device (LLD™ EZ) |
| M2045180670 | Lead Locking Device (LLD EZ) |
| M2045180621 | Lead Locking Device (LLD EZ) |
Trademark Results [LLD EZ]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LLD EZ 77309793 3562200 Live/Registered |
The Spectranetics Corporation 2007-10-22 |
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