Duns Number:832575364
Device Description: The Guardian Intraoperative Lead is a single-use, sterile medical device accessory consist The Guardian Intraoperative Lead is a single-use, sterile medical device accessory consisting of an electrode for contacting nerve, a lead wire and a connector. The connector securely connects to a Checkpoint intraoperative stimulator to provide electrical stimulation of exposed motor nerves or muscle tissue. The Medium size has lead body width of approximately 7mm.
Catalog Number
9525
Brand Name
Guardian Intraoperative Lead, Medium
Version/Model Number
9525
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K212355,K212355,K212355,K212355
Product Code
ETN
Product Code Name
Stimulator, Nerve
Public Device Record Key
108c8273-09f4-428e-ad34-bfcbfd1384b4
Public Version Date
September 10, 2021
Public Version Number
1
DI Record Publish Date
September 02, 2021
Package DI Number
B13095251
Quantity per Package
1
Contains DI Package
B13095250
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pouch