DEVICE: Checkpoint Guardian (B13090950)
Device Identifier (DI) Information
Checkpoint Guardian
9095
In Commercial Distribution
9095
Checkpoint Surgical, Inc.
9095
In Commercial Distribution
9095
Checkpoint Surgical, Inc.
Handheld Single-use Surgical Nerve Stimulator
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
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? |
---|---|---|---|---|
35723 | Nerve-locating system |
An multicomponent assembly of electrically-powered devices designed to locate a nerve by applying an electrical stimulus with a probe and observing muscle responses. Once the pathways are located, their transmission capabilities can be assessed by comparing observed muscle responses with the expected maximum contractions. The system includes an electrical pulse generator, appropriate electrodes, sensors to detect muscle response (e.g., a strain gauge), and audible and/or visual indicators it does not display electromyography (EMG) readings. It is used during the diagnosis and assessment of nerve function and to locate nerves during surgery to reduce the incidence of accidental injury.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ETN | Stimulator, Nerve |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K092292 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -20 and 55 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f350ae6e-88b7-4d6f-a648-a53332cfda98
July 02, 2021
2
July 01, 2020
July 02, 2021
2
July 01, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
B13090951 | 1 | B13090950 | In Commercial Distribution | pouch | |
B13090952 | 1 | B13090951 | In Commercial Distribution | box | |
B13090953 | 4 | B13090952 | In Commercial Distribution | shipping carton |
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
[?]
216-378-9107
regulatory@checkpointsurgical.com
regulatory@checkpointsurgical.com