Primary Device ID | M2044821100 |
NIH Device Record Key | b94321ee-8b38-4e58-b8e2-df26602ca4bc |
Commercial Distribution Discontinuation | 2019-02-06 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | Turbo Tandem™ |
Version Model Number | 482-110 |
Catalog Number | 482-110 |
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 |
Length | 110 Centimeter |
Length | 110 Centimeter |
Length | 110 Centimeter |
Length | 110 Centimeter |
Length | 110 Centimeter |
Length | 110 Centimeter |
Length | 110 Centimeter |
Length | 110 Centimeter |
Length | 110 Centimeter |
Length | 110 Centimeter |
Length | 110 Centimeter |
Length | 110 Centimeter |
Length | 110 Centimeter |
Length | 110 Centimeter |
Length | 110 Centimeter |
Length | 110 Centimeter |
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 | M2044821100 [Primary] |
MCW | Catheter, Peripheral, Atherectomy |
Steralize Prior To Use | true |
Device Is Sterile | true |
[M2044821100]
Ethylene Oxide
[M2044821100]
Ethylene Oxide
[M2044821100]
Ethylene Oxide
[M2044821100]
Ethylene Oxide
[M2044821100]
Ethylene Oxide
[M2044821100]
Ethylene Oxide
[M2044821100]
Ethylene Oxide
[M2044821100]
Ethylene Oxide
[M2044821100]
Ethylene Oxide
[M2044821100]
Ethylene Oxide
[M2044821100]
Ethylene Oxide
[M2044821100]
Ethylene Oxide
[M2044821100]
Ethylene Oxide
[M2044821100]
Ethylene Oxide
[M2044821100]
Ethylene Oxide
[M2044821100]
Ethylene Oxide
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2021-10-26 |
Device Publish Date | 2014-08-26 |
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M204472110AA0 | Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter |
M2044821100 | Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter |
M2044721100 | Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter |