FDA.reportPublic FDA data

Guardian Probe Extension, 12 cm

Primary DI
B13095040
Brand
Guardian Probe Extension, 12 cm
Company
Checkpoint Surgical, Inc.
Model
9504
Catalog number
9504
Device description
Probe Extension, 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
B13095041PackageHIBCC1In Commercial Distribution
B13095042PackageHIBCC1In Commercial Distribution
B13095043PackageHIBCC4In Commercial Distribution
B13095040PrimaryHIBCC0

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
B13095050Guardian Probe Extension Ball Tip, 12 cm950595052022-12-02
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
03662674000549DSG ConnectSPINEGUARDETN2026-10-22
00860010951705NeuralytixNEURALYTIX, LLCETN2026-10-19
00810161901562EARP NERVE CUFF ELECTRODE, 5MMRETROPSOAS TECHNOLOGIES, LLCETN2026-10-16
00810161901548EARP NERVE CUFF ELECTRODE, 3MM (Sterile)RETROPSOAS TECHNOLOGIES, LLCETN2026-10-15
00810161901555EARP NERVE CUFF ELECTRODE, 4MM (Sterile)RETROPSOAS TECHNOLOGIES, LLCETN2026-10-15
00810161901579EARP NERVE CUFF ELECTRODE, 6MM (Sterile)RETROPSOAS TECHNOLOGIES, LLCETN2026-10-15
04250307604388N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307604425N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307604449N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307613526N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307613533N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307613540N/Ainomed Medizintechnik GmbHETN2026-10-01
00763000843908NIM VitalMEDTRONIC XOMED, INC.ETN2026-08-22
00763000843915NIM VitalMEDTRONIC XOMED, INC.ETN2026-08-22
10840113234728BovieASPEN SURGICAL PRODUCTS, INC.ETN2026-08-17
00887517127693MaXcessNuvasive, Inc.ETN2026-07-27
00763000821777NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821784NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821791NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821807NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821814NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
08681823002772Bioscope Neuromonitor DeviceBIOSYS BIYOMEDIKAL MUHENDISLIK SANAYI VE TICARET ANONIM SIRKETIETN2026-06-03
00887517413673MAS PLIFNuvasive, Inc.ETN2026-04-25
00199150037407NIM™MEDTRONIC XOMED, INC.ETN2026-03-29
20199150023862N/AMEDTRONIC XOMED, INC.ETN2026-02-16
20199150023879N/AMEDTRONIC XOMED, INC.ETN2026-02-16
20199150023886N/AMEDTRONIC XOMED, INC.ETN2026-02-16
03662674000525PediGuard DSG ConnectSPINEGUARDETN2025-09-17
B006HGELS102NONENeurovision Medical Products, Inc.ETN2025-02-12
20763000842547Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26