AccessGUDID - DEVICE: Guardian Intraoperative Lead, Medium (B13095250)

GUDID

Device Identifier (DI) Information

Brand Name: Guardian Intraoperative Lead, Medium
Version or Model: 9525
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9525
Company Name: Checkpoint Surgical, Inc.

Primary DI Number: B13095250
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 832575364 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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
PDQ	Neurosurgical Nerve Locator
ETN	Stimulator, Nerve

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212355	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 7 Millimeter

Device Record Status

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

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
B13095251	1	B13095250	In Commercial Distribution	pouch
B13095252	1	B13095251	In Commercial Distribution	sales carton
B13095253	4	B13095252	In Commercial Distribution	Shipping box