FDA.reportPublic FDA data

TELIGEN

Primary DI
10705034604558
Brand
TELIGEN
Company
Medos International Sàrl
Model
286202205S
Device description
TELIGEN ACCESS PROBE WITH STIMULATION WIRE
Published
2024-02-10
Public version status
Update
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
OLOOrthopedic stereotaxic instrument
PDQNeurosurgical nerve locator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2
PDQNeurosurgical Nerve LocatorEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223108000
K223438000
K233254000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223108000TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)Medos International SARL2023-01-19OLO
K223438000TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL2023-02-10PDQ
K233254000TELIGEN System Navigation Ready InstrumentsDePuy Synthes2024-06-14OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034604558PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503460455810705034604558

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-locating system probe, single-useA hand-held surgical instrument intended to function as an electrical conductor to locate a nerve during open surgery, and for diagnostic purposes [electromyography (EMG), cortical mapping], by delivering controlled electrical impulses to a specific body site for the measurement of a neural response. It may be in the form of a needle probe or surgical forceps which is attached to an electrical pulse generator. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886705032266NA2423332423332026-07-22
10886705001309RIGIDFIX BIOCRYL2108162108162015-09-01
10705034647302CROSSNAV CONDUIT3010-21-9963010219962026-07-09
10705034647319CROSSNAV CONDUIT3010-21-9993010219992026-07-09
10705034647326CROSSNAV CONDUIT3010-21-3323010213322026-07-09
10705034647333CROSSNAV CONDUIT3010-21-3313010213312026-07-09
10705034647340CROSSNAV CONDUIT3010-21-2103010212102026-07-09
10705034647357CROSSNAV CONDUIT3010-21-2113010212112026-07-09
10705034647364CROSSNAV CONDUIT3010-21-2123010212122026-07-09
10705034647371CROSSNAV CONDUIT3010-21-2133010212132026-07-09
10705034647388CROSSNAV CONDUIT3010-21-2143010212142026-07-09
10705034647395CROSSNAV CONDUIT3010-21-2153010212152026-07-09
10705034647418CROSSNAV CONDUIT3010-21-2083010212082026-07-09
10705034647425CROSSNAV CONDUIT3010-21-2093010212092026-07-09
10705034647432CROSSNAV CONDUIT3010-21-3203010213202026-07-09
10705034647449CROSSNAV CONDUIT3010-21-3153010213152026-07-09
10705034647456CROSSNAV CONDUIT3010-21-9983010219982026-07-09
10705034647463N/A3010-21-3403010213402026-07-09
10705034647470CROSSNAV CONDUIT3010-21-3013010213012026-07-09
10705034647487CROSSNAV CONDUIT3010-21-3033010213032026-07-09

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