TorqMax™ 502-001
GUDID M204502001AA0
TorqMax™ Sheath Grip Assembly
Spectranetics Corporation
Torque manipulation device| Primary Device ID | M204502001AA0 |
| NIH Device Record Key | 7417c4fa-d9a8-4ad5-aa19-ae713d837408 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TorqMax™ |
| Version Model Number | 502-001AA |
| Catalog Number | 502-001 |
| 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 | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| complaints@spnc.com | |
| Phone | 1-800-633-0969 |
| 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
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Outer Diameter | 7.5 Millimeter |
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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813132020446 [Primary] |
| GS1 | 20813132020440 [Package] Contains: 00813132020446 Package: Box [2 Units] In Commercial Distribution |
| HIBCC | M204502001AA0 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K093257
FDA Product Code
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control |
| OFC | Catheter Introducer Kit |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M204502001AA0]
Ethylene Oxide
[M204502001AA0]
Ethylene Oxide
[M204502001AA0]
Ethylene Oxide
[M204502001AA0]
Ethylene Oxide
[M204502001AA0]
Ethylene Oxide
[M204502001AA0]
Ethylene Oxide
[M204502001AA0]
Ethylene Oxide
[M204502001AA0]
Ethylene Oxide
[M204502001AA0]
Ethylene Oxide
[M204502001AA0]
Ethylene Oxide
[M204502001AA0]
Ethylene Oxide
[M204502001AA0]
Ethylene Oxide
[M204502001AA0]
Ethylene Oxide
[M204502001AA0]
Ethylene Oxide
[M204502001AA0]
Ethylene Oxide
[M204502001AA0]
Ethylene Oxide
[M204502001AA0]
Ethylene Oxide
[M204502001AA0]
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 [TorqMax™]
| M204502001AA0 | TorqMax™ Sheath Grip Assembly |
| M2045020011 | TorqMax™ Sheath Grip Assembly |
Trademark Results [TorqMax]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TORQMAX 87318311 not registered Dead/Abandoned |
HAIMER USA 2017-01-30 |
 TORQMAX 86940145 5398952 Live/Registered |
Nidec Motor Corporation 2016-03-15 |
 TORQMAX 85911746 4450758 Live/Registered |
SHORES LIFT SOLUTIONS, INC. 2013-04-23 |
 TORQMAX 78949831 3312567 Dead/Cancelled |
SCHAEFFLER TECHNOLOGIES GMBH & CO. KG 2006-08-10 |
 TORQMAX 77602572 3832560 Live/Registered |
The Spectranetics Corporation 2008-10-28 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.