TorqMax™ 502-001
GUDID M204502001AA0
TorqMax™ Sheath Grip Assembly
Spectranetics Corporation
Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device 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 |
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 |
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 |
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 |
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