FDA.reportPublic FDA data

Guardian Probe Extension Ball Tip, 12 cm

Primary DI
B13095050
Brand
Guardian Probe Extension Ball Tip, 12 cm
Company
Checkpoint Surgical, Inc.
Model
9505
Catalog number
9505
Device description
Probe Extension with Ball Tip, 12 cm for use with Checkpoint Stimulators
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETNStimulator, Nerve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092292000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092292000CHECKPOINTNdi Medical, LLC2009-10-28ETN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B13095051PackageHIBCC1In Commercial Distribution
B13095052PackageHIBCC1In Commercial Distribution
B13095053PackageHIBCC4In Commercial Distribution
B13095050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-locating systemAn 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.

Contacts#

Phone, Email table
PhoneEmail
2163789107regulatory@checkpointsurgical.com

Regulatory Flags#

DUNS number
832575364
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B130NS30200Checkpoint NeuroShield Chitosan MembraneNS3020NS30202023-03-31
B130PV40300ProVeil Hydrogel MembranePV4030PV40302023-03-31
B130NS3020K23Checkpoint Nerve Repair KitNS3020K2NS3020K22023-09-01
B130NS4030K13Checkpoint Nerve Repair KitNS4030K1NS4030K12023-09-01
B130NS40300Checkpoint NeuroShield Chitosan MembraneNS4030NS40302023-03-31
B13095240Guardian Intraoperative Lead, Small952495242023-06-01
B13095241Guardian Intraoperative Lead, Small952495242023-06-01
B130NS30201Checkpoint NeuroShield Chitosan MembraneNS3020NS30202023-03-31
B130PV40301ProVeil Hydrogel MembranePV4030PV40302023-03-31
B13095040Guardian Probe Extension, 12 cm950495042022-12-02
B13095060Guardian Probe Extension, 4 cm950695062022-12-02
B13095041Guardian Probe Extension, 12 cm950495042022-12-02
B13095051Guardian Probe Extension Ball Tip, 12 cm950595052022-12-02
B13095061Guardian Probe Extension, 4 cm950695062022-12-02
B13092500Checkpoint Edge Nerve Cutting Kit925092502022-05-09
B13092501Checkpoint Edge Nerve Cutting Kit925092502022-05-09
B13090920Checkpoint Gemini909290922022-03-30
B13090921Checkpoint Gemini909290922022-03-30
B13095250Guardian Intraoperative Lead, Medium952595252021-09-02
B13095251Guardian Intraoperative Lead, Medium952595252021-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20199150023862N/AMEDTRONIC XOMED, INC.ETN2026-02-16
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20199150023886N/AMEDTRONIC XOMED, INC.ETN2026-02-16
B006NVHS102NONENeurovision Medical Products, Inc.ETN2025-12-18
B006HGELS102NONENeurovision Medical Products, Inc.ETN2025-02-12
B006NVPS2Nerveäna+®Neurovision Medical Products, Inc.ETN2025-02-11
20763000842547Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
20763000842554Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
20763000842561Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
10887482176853BovieASPEN SURGICAL PRODUCTS, INC.ETN2024-08-27
08720791376451Technomed EuropeTechnomed Engineering B.V.ETN2024-05-06
08720791376475Technomed EuropeTechnomed Engineering B.V.ETN2024-05-06
08720791376482Technomed EuropeTechnomed Engineering B.V.ETN2024-05-06
08720791373634NeuroradiumTechnomed Engineering B.V.ETN2024-02-12
08720791373665NeuroradiumTechnomed Engineering B.V.ETN2024-02-12
B006NVPTKITC3P6WSF52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITC3P7WSF52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITC3P8WSF52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITDCLD52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITDCLWF52Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITDCSD52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITDCSWF52Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPMK1Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPSTST2Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPT1Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPUSB1Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006IDKWSF51252ScorpionNeurovision Medical Products, Inc.ETN2023-09-01
B006NVPTKITC3P652Nerveana+®Neurovision Medical Products, Inc.ETN2023-04-20
B006NVPTKITC3P6T52Nerveana+®Neurovision Medical Products, Inc.ETN2023-04-20
B006NVPTKITC3P752Nerveana+®Neurovision Medical Products, Inc.ETN2023-04-20