Primary Device ID | 00813132020743 |
NIH Device Record Key | 13df9ef7-ed13-43b6-924e-335f2882845d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | LLD™ #1 |
Version Model Number | 518-018AA |
Catalog Number | 518-018 |
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 | 1-800-633-0960 |
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 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00813132020743 [Primary] |
GS1 | 20813132020747 [Package] Package: Box [3 Units] In Commercial Distribution |
HIBCC | M204518018AA0 [Secondary] |
DRB | Stylet, Catheter |
Steralize Prior To Use | true |
Device Is Sterile | true |
[00813132020743]
Ethylene Oxide
[00813132020743]
Ethylene Oxide
[00813132020743]
Ethylene Oxide
[00813132020743]
Ethylene Oxide
[00813132020743]
Ethylene Oxide
[00813132020743]
Ethylene Oxide
[00813132020743]
Ethylene Oxide
[00813132020743]
Ethylene Oxide
[00813132020743]
Ethylene Oxide
[00813132020743]
Ethylene Oxide
[00813132020743]
Ethylene Oxide
[00813132020743]
Ethylene Oxide
[00813132020743]
Ethylene Oxide
[00813132020743]
Ethylene Oxide
[00813132020743]
Ethylene Oxide
[00813132020743]
Ethylene Oxide
[00813132020743]
Ethylene Oxide
[00813132020743]
Ethylene Oxide
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2015-02-06 |
M204518021AB0 | Lead Locking Device (LLD™ #1) |
M204518018AB0 | Lead Locking Device (LLD™ #1) |
M204518021AA0 | Lead Locking Device (LLD™ #1) |
00813132020743 | Lead Locking Device (LLD™ #1) |
M2045180210 | Lead Locking Device (LLD #1) |
M2045180181 | Lead Locking Device (LLD #1) |