FDA.reportPublic FDA data

Guardian Intraoperative Lead, Medium

Primary DI
B13095251
Brand
Guardian Intraoperative Lead, Medium
Company
Checkpoint Surgical, Inc.
Model
9525
Catalog number
9525
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.
Published
2021-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PDQNeurosurgical Nerve Locator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PDQNeurosurgical Nerve LocatorEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212355000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212355000Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, LargeCheckpoint Surgical2021-08-26ETN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B13095251PackageHIBCC1In Commercial Distribution
B13095252PackageHIBCC1In Commercial Distribution
B13095253PackageHIBCC4In Commercial Distribution
B13095250PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width7Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2163789107regulatory@checkpointsurgical.com

Regulatory Flags#

DUNS number
832575364
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M68980801D160Fresh Whole Blood Donor Transfusion SetSafeguard US Operating, LLCPDQ2026-05-04
00843059126945MedtronicTEDAN SURGICAL INNOVATIONS, L.L.C.PDQ2026-04-28
00843059126990MedtronicTEDAN SURGICAL INNOVATIONS, L.L.C.PDQ2026-04-28
00190376509747SafeOp 3ALPHATEC SPINE, INC.PDQ2026-03-24
00840067103555Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-11-15
00840067103562Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-11-15
00840067103623Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-11-15
00840067103630Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-11-15
00190376517506SafeOp 3ALPHATEC SPINE, INC.PDQ2024-11-12
00190376530024SafeOp 3ALPHATEC SPINE, INC.PDQ2024-11-12
00840067102992Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-08-23
00190376549392SafeOp 3ALPHATEC SPINE, INC.PDQ2024-07-12
00840067103517Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-06-21
00840067103524Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-06-21
00840067102879Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-03-04
00840067102886Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-03-04
00840067102893Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-03-04
00840067102916Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-03-04
00840067103609Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-03-04
10705034604527TELIGENMedos International SàrlPDQ2024-02-10
00195377153951PULSENuvasive, Inc.PDQ2023-07-11
00195377153968PULSENuvasive, Inc.PDQ2023-07-11
00195377153975PULSENuvasive, Inc.PDQ2023-07-11
00195377060761PULSENuvasive, Inc.PDQ2023-07-06
00195377060778PULSENuvasive, Inc.PDQ2023-07-06
00195377099013PULSENuvasive, Inc.PDQ2023-07-06
00195377153807PULSENuvasive, Inc.PDQ2023-05-02
00195377153814PULSENuvasive, Inc.PDQ2023-05-02
00195377097422NVM5Nuvasive, Inc.PDQ2023-04-13
00195377097439NVM5Nuvasive, Inc.PDQ2023-04-13