FDA.reportPublic FDA data

K.T.Surgico

Primary DI
KTS0025716
Brand
K.T.Surgico
Company
K.T.SURGICO
Model
2024
Catalog number
KTS0025716
Device description
Otoscope
Published
2024-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ERAOtoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERAOtoscopeEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
MASTER90PackageHIBCC50Not in Commercial Distribution
KTS0025716PrimaryHIBCC0
TMS1332504Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Otoscope, directAn electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head.

Contacts#

Phone, Email table
PhoneEmail
630-279-5000oahmed@tmsmed.net

Regulatory Flags#

DUNS number
645493024
Device count
50
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
KTS0816014K.T.Surgico2025KTS08160142025-03-15
KTS0816017K.T.Surgico2025KTS08160172025-03-15
KTS0816114K.T.Surgico2025KTS08161142025-03-15
KTS0816117K.T.Surgico2025KTS08161172025-03-15
KTS0834311K.T.Surgico2025KTS08343112025-03-15
KTS0890118K.T.Surgico2025KTS08901182025-03-15
MAYOSTR01K.T.Surgico2025KTS08160142025-03-15
MAYOSTR02K.T.Surgico2025KTS08160172025-03-15
MAYOCVD01K.T.Surgico2025KTS08161142025-03-15
MAYOCVD02K.T.Surgico2025KTS08161172025-03-15
IRISCVD01K.T.Surgico2025KTS08343112025-03-15
BANDAGE02K.T.Surgico2025KTS08901182025-03-15
KTS0811416K.T.Surgico2025KTS08114162025-03-13
KTS0810214K.T.Surgico2025KTS08102142025-03-12
KTS0890114K.T.Surgico2025KTS08901142025-03-12
SCISSORBB01K.T.Surgico2025KTS08102142025-03-12
BANDAGE01K.T.Surgico2025KTS08901142025-03-12
KTS0834211K.T.Surgico2023KTS08342112024-02-20
KTS0811011K.T.Surgico2023KTS08801112024-02-20
KTS0811014K.T.Surgico2023KTS08110142024-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00634782102456Diagnostix™AMERICAN DIAGNOSTIC CORPERA2026-10-06
04260381960164LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381960188LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381960195LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381960218LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381963493LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381963509LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381964353LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381964360LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381964377LuxamedLuxamed GmbH & Co. KGERA2026-08-26
05713315012341Aurical Otocam 300-IIINatus Medical Denmark ApSERA2026-07-20
06972545090485JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-07-17
16972545090154JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-07-17
04260154547271OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547400OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547417OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547424OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547448OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547455OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547462OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547479OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547486OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547493OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547530OTOPRONTHappersberger Otopront GmbHERA2026-07-08
16972545090017JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-05-18
16972545090031JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-05-18
00050428029497CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDERA2026-02-13
00311917035000WalgreensWALGREEN CO.ERA2023-11-01
20884392954455Safety 1stDOREL JUVENILE GROUP, INC.ERA2023-10-15
10884389104514MedlineMEDLINE INDUSTRIES, INC.ERA2023-01-21