DEVICE: TorqMax™ (M2045020010)
Device Identifier (DI) Information
TorqMax™
502-001
Not in Commercial Distribution
502-001
Spectranetics Corporation
502-001
Not in Commercial Distribution
502-001
Spectranetics Corporation
TorqMax™ Sheath Grip Assembly
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
46455 | Torque manipulation device |
A sterile hand-operated device intended to be attached to the proximal end of an invasive device (e.g., a catheter, a needle, or a guidewire) to provide the operator with the ability to manually manipulate and control the directional torque (rotation) of the device to which it is attached. This device may be made of plastic or metal materials. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: less than 140 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 7.5 Millimeter |
Device Record Status
2f9fb1ef-1dab-47a0-b031-81f1ff41a435
October 26, 2021
5
August 19, 2014
October 26, 2021
5
August 19, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
M2045020011 | 2 | M2045020010 | 2019-02-06 | Not in Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-633-0969
complaints@spnc.com
complaints@spnc.com