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

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
10705034442280EXPEDIUM VERSE™ SPINE SYSTEM1997216401997216402015-09-24
10705034442587EXPEDIUM VERSE™ SPINE SYSTEM1997214601997214602015-09-24
10705034369761SKYLINE4102701124102701122016-12-31
10705034369778SKYLINE4102701164102701162016-12-31
10705034369785SKYLINE4102701204102701202016-12-31
10705034369822SKYLINE4102702284102702282016-12-31
10705034369839SKYLINE4102702324102702322016-12-31
10705034369846SKYLINE4102702364102702362016-12-31
10705034369884SKYLINE4102703424102703422016-12-31
10705034369891SKYLINE4102703484102703482016-12-31
10705034369907SKYLINE4102703544102703542016-12-31
10705034369983SKYLINE4102901304102901302016-12-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03662674000549DSG ConnectSPINEGUARDPDQ2026-10-22
00860010951705NeuralytixNEURALYTIX, LLCPDQ2026-10-19
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