FDA.reportPublic FDA data

SENTIO

Primary DI
10705034560366
Brand
SENTIO
Company
Medos International Sàrl
Model
186002110S
Catalog number
186002110S
Device description
SENTIO MMG STIMULATION WIRE
Published
2023-03-01
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
PDQNeurosurgical nerve locator

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223438000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223438000TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL2023-02-10PDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034560366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503456036610705034560366

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034648194VELYS4516110654516110652026-10-09
10705034648200VELYS4516110644516110642026-10-09
00856879006519FIBERGRAFT Aeridyan59000170590001702026-09-29
00856879006908FIBERGRAFT Aeridyan Matrix73000030730000302023-04-05
00856879006915FIBERGRAFT Aeridyan Matrix73000063730000632023-04-05
00856879006922FIBERGRAFT Aeridyan Matrix73000125730001252023-04-05
00856879006946FIBERGRAFT Aeridyan Matrix73000200730002002023-04-05
00856879006250FIBERGRAFT Aeridyan Matrix59000125590001252021-08-04
00856879006281FIBERGRAFT Aeridyan Matrix59000063590000632021-08-04
00856879006298FIBERGRAFT Aeridyan Matrix59000015590000152021-08-04
00856879006304FIBERGRAFT Aeridyan Matrix59000030590000302021-08-04
00856879006311FIBERGRAFT Aeridyan Matrix59000200590002002021-08-04
00856879006526FIBERGRAFT BG Matrix55000170550001702021-05-24
00856879006700FIBERGRAFT BG Morsels77000110770001102021-05-19
00856879006717FIBERGRAFT BG Morsels77000060770000602021-05-19
00856879006724FIBERGRAFT BG Morsels77000020770000202021-05-19
00856879006731FIBERGRAFT BG Putty78000110780001102021-05-19
00856879006748FIBERGRAFT BG Putty78000060780000602021-05-19
00856879006755FIBERGRAFT BG Putty78000040780000402021-05-19
00856879006762FIBERGRAFT BG Putty78000020780000202021-05-19

Other Devices Sharing Product Codes#

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
03662674000525PediGuard DSG ConnectSPINEGUARDPDQ2025-09-17
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